What is NDC 57631-010?

57631-010 is the product NDC for Acetaminophen and Diphenhydramine citrate, Acetaminophen 500 mg/1; Diphenhydramine citrate 38 mg/1 tablet, listed with the FDA by InvaTech Pharma Solutions LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Acetaminophen and Diphenhydramine citrate.

What is the active ingredient?

Acetaminophen, Diphenhydramine citrate.

InvaTech Pharma Solutions LLC, NDC labeler code 57631. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Acetaminophen and Diphenhydramine citrate?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

NDC 57631-010

NDC codes

FDA NDC Directory

Product NDC (as listed)57631-010Labeler and product segments. Claims need a package NDC.

Product NDC at billing width57631-0010Add 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
57631-010-00	5763100100057631001000	30000 TABLET in 1 BOX (57631-010-00)Marketed from Oct 1, 2025

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): Acetaminophen and Diphenhydramine citrate
Generic name (nonproprietary): acetaminophen and diphenhydramine citrate
Active ingredients: Acetaminophen — 500 mg/1Diphenhydramine citrate — 38 mg/1
Dosage form: Tablet
Route: Oral
Labeler: InvaTech Pharma Solutions LLCNDC labeler code 57631
Product type: Over-the-counter drug
Marketing category: OTC monograph drugApplication M 012
Marketing start: Oct 1, 2025
Listing expires: Dec 31, 2026
Other FDA classes: Histamine H1 Receptor Antagonists (Mechanism)
Identifiers: Product ID 57631-010_403a87a6-fe92-8e79-e063-6394a90a70ceSPL ID 403a87a6-fe92-8e79-e063-6394a90a70ceSPL set ID 403a88fa-e06b-9b6e-e063-6394a90a97b8RxCUI 1099872UNII 362O9ITL9D, 4OD433S209
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

N457631001000 followed by a unit qualifier and the quantity

Package 57631-0010-00. 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 Oct 2, 2025.

Indications (excerpt from the label)

Analgesic and Antipyretic

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 57631-010

What is NDC 57631-010?: 57631-010 is the product NDC for Acetaminophen and Diphenhydramine citrate, Acetaminophen 500 mg/1; Diphenhydramine citrate 38 mg/1 tablet, listed with the FDA by InvaTech Pharma Solutions LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Acetaminophen and Diphenhydramine citrate.
What is the active ingredient?: Acetaminophen, Diphenhydramine citrate.
Who is the labeler?: InvaTech Pharma Solutions LLC, NDC labeler code 57631. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Acetaminophen and Diphenhydramine citrate?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

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
Daytime Cold and Flu Reliefacetaminohpen, dextromethorphan hbr, guaifenesin phenylephrine hcl	Acetaminophen 650 mg/30mL + 3 more ingredients	LiquidOral	The Kroger Co.	30142-722
Cold Fluacetaminophen, dextromethorphan hydrobromide, doxylamine succinate	—	Kit	HyVee Inc	42507-598
Allergy Reliefdiphenhydramine hcl	Diphenhydramine hydrochloride 25 mg/1	Tablet, Film coatedOral	H E B	37808-932
Medi First Plus Cherry Cough Dropsmenthol	Menthol 7.6 mg/1	LozengeOral	Unifirst First Aid Corporation	47682-915
Supress Adexbromopheniramine maleate, dextromethorphan hbr, phenylephrine hcl	Dexbrompheniramine maleate 1 mg/mL + 2 more ingredients	SyrupOral	Kramer Novis	52083-057
SAFETUSSIN Non Drowsy Cough plus chest congestiondextromethorphan hydrobromide, and guaifenesin	Dextromethorphan hydrobromide 10 mg/1; Guaifenesin 200 mg/1	TabletOral	KRAMER LABORATORIES	55505-231
Tusnel-DM Pediatricdextromethorphan hbr, guaifenesin, phenylephrine hcl	Dextromethorphan hydrobromide 2.5 mg/mL + 2 more ingredients	Solution/ dropsOral	LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION	54859-606
Dg Health Cold Flu Reliefacetaminophen, dextromethorphan hydrobromide, doxylamine succinate	Acetaminophen 325 mg/15mL + 2 more ingredients	SolutionOral	Dolgencorp Inc	55910-753
MUCINEX SINUS-MAX SEVERE CONGESTION RELIEF SINUS and ALLERGYoxymetazoline hydrochloride	Oxymetazoline hydrochloride .05 g/100mL	SolutionNasal	Reckitt Benckiser LLC	63824-120
Vicks Sinex SEVERE CONGESTIONoxymetazoline hydrochloride	Oxymetazoline hydrochloride .0005 g/mL	SprayNasal	Procter & Gamble Manufacturing GmbH	64336-002
Walgreens Honey Lemon Cough Dropsmenthol	Menthol 7.5 mg/1	LozengeOral	Walgreens	0363-9959
Tesalon Jarabe Adultoacetaminophen, dextromethorphan hbr, guaifenesin usp, phenylephrine hcl	Acetaminophen 500 mg/20mL + 3 more ingredients	SyrupOral	OPMX LLC	69729-787
Guaifenesin	Guaifenesin 400 mg/1	TabletOral	Bryant Ranch Prepack	71335-9616
Cold Head Congestion Severeacetaminophen, guaifenesin, and phenylephrine hydrochloride	Acetaminophen 325 mg/1 + 2 more ingredients	Tablet, CoatedOral	Harris Teeter	72036-175
DG Health Cough Drops Cherry Flavormenthol	Menthol 5.8 mg/1	LozengeTopical	Dollar General Corporation	75712-005
Nuvicare NightTime Cold and Flu Softgelacetaminophen, dextromethorphan hydrobromide, doxylamine succinate	Acetaminophen 325 mg/1 + 2 more ingredients	Capsule, Liquid filledOral	NUVICARE LLC	84324-019
Quality Choice Mucus Reliefguaifenesin	Guaifenesin 400 mg/1	TabletOral	Chain Drug Marketing Association	83324-194
Diphenhydramine HCl	Diphenhydramine hydrochloride 12.5 mg/5mL	SolutionOral	Major Pharmaceuticals	0904-6985
severe cold and flu reliefacetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride	Acetaminophen 325 mg/15mL + 3 more ingredients	SolutionOral	Rite Aid Corporation	11822-3120
Supress Dx Pediatric Dropsdextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride	Dextromethorphan hydrobromide 5 mg/mL + 2 more ingredients	SyrupOral	Kramer Novis	52083-051

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Acetaminophen and Diphenhydramine citrate NDC 57631-010