What is NDC 76457-002?

76457-002 is the product NDC for diphenhydramine hydrochloride, Diphenhydramine hydrochloride 25 mg/1 tablet, listed with the FDA by Simpex Pharma Pvt. Ltd. It has 1 package NDC, shown above in 10- and 11-digit form.

Simpex Pharma Pvt. Ltd, NDC labeler code 76457. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for diphenhydramine hydrochloride?

77 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

diphenhydramine hydrochloride NDC 76457-002

NDC codes

FDA NDC Directory

Product NDC (as listed)76457-002Labeler and product segments. Claims need a package NDC.

Product NDC at billing width76457-0002Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
76457-002-00	7645700020076457000200	1 BOTTLE in 1 CARTON (76457-002-00) / 100 TABLET in 1 BOTTLEMarketed from Feb 9, 2018

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): diphenhydramine hydrochloride
Generic name (nonproprietary): diphenhydramine hydrochloride
Active ingredients: Diphenhydramine hydrochloride — 25 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Simpex Pharma Pvt. LtdNDC labeler code 76457
Product type: Over-the-counter drug
Marketing category: OTC monograph drugApplication M 012
Marketing start: Feb 9, 2018
Listing expires: Dec 31, 2026
Other FDA classes: Histamine H1 Receptor Antagonists (Mechanism)
Identifiers: Product ID 76457-002_0b586170-9b5f-74dc-e063-6394a90aa09bSPL ID 0b586170-9b5f-74dc-e063-6394a90aa09bSPL set ID 82771f6a-8b3d-4ffa-8b35-09c2faf3582cRxCUI 1049630UNII TC2D6JAD40
Pharmacologic class: Histamine-1 Receptor Antagonist

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N476457000200 followed by a unit qualifier and the quantity

Package 76457-0002-00. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Nov 29, 2023.

Indications (excerpt from the label)

Uses temporarily relieves symptoms due to common cold, hay fever or other allergies affecting the upper respiratory tract runny nose sneezing Itchy watery eyes Itching of the nose or throat.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 76457-002

What is NDC 76457-002?: 76457-002 is the product NDC for diphenhydramine hydrochloride, Diphenhydramine hydrochloride 25 mg/1 tablet, listed with the FDA by Simpex Pharma Pvt. Ltd. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: diphenhydramine hydrochloride.
What is the active ingredient?: Diphenhydramine hydrochloride.
Who is the labeler?: Simpex Pharma Pvt. Ltd, NDC labeler code 76457. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for diphenhydramine hydrochloride?: 77 other product NDCs are listed under this name. See all diphenhydramine hydrochloride NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other diphenhydramine hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Diphenhydramine Hydrochloride	Diphenhydramine hydrochloride 25 mg/1	TabletOral	Cardinal Health 107, LLC	55154-1589	55154-1589-00
Diphenhydramine Hydrochloride	Diphenhydramine hydrochloride 25 mg/1	Tablet, Film coatedOral	Health Pharma USA LLC	71679-308	71679-0308-00
Diphenhydramine hydrochloride	Diphenhydramine hydrochloride 12.5 mg/5mL	SolutionOral	Camber Pharmaceuticals, Inc.	31722-600	31722-0600-1131722-0600-31
Diphenhydramine hydrochloride	Diphenhydramine hydrochloride 25 mg/10mL	SolutionOral	Camber Pharmaceuticals, Inc.	31722-601	31722-0601-31
Diphenhydramine Hydrochloride	Diphenhydramine hydrochloride 50 mg/mL	InjectionIntramuscular, Intravenous	REMEDYREPACK INC.	70518-4536	70518-4536-00
Diphenhydramine Hydrochloride	Diphenhydramine hydrochloride 50 mg/mL	InjectionIntramuscular, Intravenous	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-263	23155-0263-31
Diphenhydramine Hydrochloride	Diphenhydramine hydrochloride 50 mg/mL	InjectionIntramuscular, Intravenous	Micro Labs Limited	42571-511	42571-0511-56
Diphenhydramine hydrochloride	Diphenhydramine hydrochloride 50 mg/mL	InjectionIntramuscular, Intravenous	REMEDYREPACK INC.	70518-4455	70518-4455-00
Diphenhydramine Hydrochloride	Diphenhydramine hydrochloride 50 mg/1	Capsule, Liquid filledOral	Prodose, Inc.	68210-5057	68210-5057-01
Diphenhydramine Hydrochloride	Diphenhydramine hydrochloride 50 mg/mL	InjectionIntramuscular, Intravenous	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-264	23155-0264-41

All 78 diphenhydramine hydrochloride NDCs

Other NDCs under M 012

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under M 012
Product	Strength	Form · route	Labeler	Product NDC
Allergy Reliefdiphenhydramine hydrochloride	Diphenhydramine hydrochloride 25 mg/1	Tablet, Film coatedOral	WALGREENS	0363-0100
CVS Health No Dripnasal mist	Oxymetazoline hydrochloride .05 g/100mL	SprayNasal	CVS PHARMACY,INC.	69842-815
Vicks NyQuil VapoCOOL Severe COLD and FLU plus CONGESTIONacetaminophen, phenylephrine hydrochloride, doxylamine succinate, and dextromethorphan hydrobromide	Acetaminophen 325 mg/1 + 3 more ingredients	Tablet, CoatedOral	The Procter & Gamble Manufacturing Company	69423-986
Cold and Flu Nighttimeacetaminophen, dextromethorphan hbr, doxylamine succinate	Acetaminophen 650 mg/30mL + 2 more ingredients	SolutionOral	Lidl US LLC	71141-180
basic care tussin dm maxdextromethorphan hbr, guaifenesin	Dextromethorphan hydrobromide 20 mg/20mL; Guaifenesin 400 mg/20mL	SolutionOral	Amazon.com Services LLC	72288-293
Menthol Cough Drops Honey Vanilla Flavormenthol	Menthol 2.5 mg/1	LozengeOral	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	83698-013
equate daytime nighttime cold and fluacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, guaifenesen, phenylephrine hydrochloride	—	Kit	Sixarp, LLC	59368-459
Nasal Decongestant Maximum Strengthpseudoephedrine hcl	Pseudoephedrine hydrochloride 30 mg/1	Tablet, Film coatedOral	Better Living Brands, LLC	21130-112
Medicated Chest Rubcamphor, menthol, eucalyptus oil	Camphor (Synthetic) 4.8 g/100g + 2 more ingredients	CreamTopical	Jell Pharmaceuticals Pvt Ltd.	30400-701
equaline nighttime cold and flu reliefacetaminophen, dextromethorphan hbr, doxylamine succinate	Acetaminophen 650 mg/30mL + 2 more ingredients	SolutionOral	United Natural Foods, Inc. dba UNFI	41163-459
NiteTime Cold and Fluacetaminophen, dextromethorphan hydrobromide, doxylamine succinate	Acetaminophen 650 mg/30mL + 2 more ingredients	LiquidOral	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)	49035-044
Childrens Dye Free Allergydiphenhydramine hydrochloride	Diphenhydramine hydrochloride 12.5 mg/5mL	LiquidOral	P & L Development, LLC	49580-0293
Discount Drug Mart Original Nasaloxymetazoline hydrochloride	Oxymetazoline hydrochloride .05 g/100mL	SprayNasal	DISCOUNT DRUG MART	53943-715
Cold, Flu and Sore Throatacetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl	Acetaminophen 650 mg/20mL + 3 more ingredients	SolutionOral	Family Dollar Services Inc	55319-705
DG Health Cold and Flu Severeacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride	Acetaminophen 325 mg/15mL + 3 more ingredients	SolutionOral	Dolgencorp Inc	55910-928
Robitussin Severe Multi-Symptom Cough Cold Fluacetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride	Acetaminophen 650 mg/20mL + 3 more ingredients	LiquidOral	Haleon US Holdings LLC	0031-8751
Afrin No Drip Pump Mist Bundle Packoxymetazoline hydrochloride	—	KitNasal	Bayer HealthCare LLC.	11523-0147
Cold Medicine XL3acetaminophen chlorpheniramine maleate phenylepherine hydrochloride	Acetaminophen 325 mg/1 + 2 more ingredients	TabletOral	Selder, S.A. de C.V.	63654-605
Nasal Spray, 1oz, 24/7 Life by 7-Elevenoxymetazoline hcl nasal solution 0.05%	Oxymetazoline hydrochloride .05 g/100mL	SprayNasal	Lil' Drug Store Products, Inc.	66715-5526
Vicks childrens Cough Congestionphenylephrine hcl, dextromethorphan hbr, guaifenesin	Dextromethorphan hydrobromide 10 mg/15mL + 2 more ingredients	LiquidOral	The Procter & Gamble Manufacturing Company	69423-982

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