NDC codes

FDA NDC Directory
Product NDC (as listed)57243-190Labeler and product segments. Claims need a package NDC.
Product NDC at billing width57243-0190Add 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 NDC11-digit (billing)PackageCopy
57243-190-0857243019008572430190082 BLISTER PACK in 1 CARTON (57243-190-08) / 12 CAPSULE in 1 BLISTER PACKMarketed from Mar 15, 1990

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)
Complete Allergy Medicine
Generic name (nonproprietary)
diphenhydramine hcl
Active ingredients
Diphenhydramine hydrochloride — 25 mg/1
Dosage form
Capsule
Route
Oral
Labeler
Salado Sales, Inc.NDC labeler code 57243
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication M 012
Marketing start
Listing expires
Other FDA classes
Histamine H1 Receptor Antagonists (Mechanism)
Identifiers
Product ID 57243-190_45283399-3bf4-4563-9b83-ae4b600b0f1aSPL ID 45283399-3bf4-4563-9b83-ae4b600b0f1aSPL set ID c0f5c8ca-b187-40bf-9245-6a29f1c32c97RxCUI 1049909UNII TC2D6JAD40UPC 0761706161043
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

N457243019008 followed by a unit qualifier and the quantity

Package 57243-0190-08. 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 .

Indications (excerpt from the label)

Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itchy, watery eyes sneezing itching of the nose or throat temporarily relieves these symptoms due to the common cold: runny nose sneezing

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 57243-190

What is NDC 57243-190?
57243-190 is the product NDC for Complete Allergy Medicine (diphenhydramine hcl), Diphenhydramine hydrochloride 25 mg/1 capsule, listed with the FDA by Salado Sales, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Complete Allergy Medicine (Diphenhydramine HCl).
What is the active ingredient?
Diphenhydramine hydrochloride.
Who is the labeler?
Salado Sales, Inc., NDC labeler code 57243. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Complete Allergy Medicine?
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
ProductStrengthForm · routeLabelerProduct NDC
Allergy Reliefdiphenhydramine hydrochlorideDiphenhydramine hydrochloride 25 mg/1Tablet, Film coatedOralWALGREENS0363-0100
CVS Health No Dripnasal mistOxymetazoline hydrochloride .05 g/100mLSprayNasalCVS PHARMACY,INC.69842-815
Vicks NyQuil VapoCOOL Severe COLD and FLU plus CONGESTIONacetaminophen, phenylephrine hydrochloride, doxylamine succinate, and dextromethorphan hydrobromideAcetaminophen 325 mg/1 + 3 more ingredientsTablet, CoatedOralThe Procter & Gamble Manufacturing Company69423-986
Cold and Flu Nighttimeacetaminophen, dextromethorphan hbr, doxylamine succinateAcetaminophen 650 mg/30mL + 2 more ingredientsSolutionOralLidl US LLC71141-180
basic care tussin dm maxdextromethorphan hbr, guaifenesinDextromethorphan hydrobromide 20 mg/20mL; Guaifenesin 400 mg/20mLSolutionOralAmazon.com Services LLC72288-293
Menthol Cough Drops Honey Vanilla FlavormentholMenthol 2.5 mg/1LozengeOralXiamen Kang Zhongyuan Biotechnology Co., Ltd.83698-013
equate daytime nighttime cold and fluacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, guaifenesen, phenylephrine hydrochloride—KitSixarp, LLC59368-459
Nasal Decongestant Maximum Strengthpseudoephedrine hclPseudoephedrine hydrochloride 30 mg/1Tablet, Film coatedOralBetter Living Brands, LLC21130-112
Medicated Chest Rubcamphor, menthol, eucalyptus oilCamphor (Synthetic) 4.8 g/100g + 2 more ingredientsCreamTopicalJell Pharmaceuticals Pvt Ltd.30400-701
equaline nighttime cold and flu reliefacetaminophen, dextromethorphan hbr, doxylamine succinateAcetaminophen 650 mg/30mL + 2 more ingredientsSolutionOralUnited Natural Foods, Inc. dba UNFI41163-459
NiteTime Cold and Fluacetaminophen, dextromethorphan hydrobromide, doxylamine succinateAcetaminophen 650 mg/30mL + 2 more ingredientsLiquidOralEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)49035-044
Childrens Dye Free Allergydiphenhydramine hydrochlorideDiphenhydramine hydrochloride 12.5 mg/5mLLiquidOralP & L Development, LLC49580-0293
Discount Drug Mart Original Nasaloxymetazoline hydrochlorideOxymetazoline hydrochloride .05 g/100mLSprayNasalDISCOUNT DRUG MART53943-715
Cold, Flu and Sore Throatacetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hclAcetaminophen 650 mg/20mL + 3 more ingredientsSolutionOralFamily Dollar Services Inc55319-705
DG Health Cold and Flu Severeacetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochlorideAcetaminophen 325 mg/15mL + 3 more ingredientsSolutionOralDolgencorp Inc55910-928
Robitussin Severe Multi-Symptom Cough Cold Fluacetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochlorideAcetaminophen 650 mg/20mL + 3 more ingredientsLiquidOralHaleon US Holdings LLC0031-8751
Afrin No Drip Pump Mist Bundle Packoxymetazoline hydrochloride—KitNasalBayer HealthCare LLC.11523-0147
Cold Medicine XL3acetaminophen chlorpheniramine maleate phenylepherine hydrochlorideAcetaminophen 325 mg/1 + 2 more ingredientsTabletOralSelder, 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/100mLSprayNasalLil' Drug Store Products, Inc.66715-5526
Vicks childrens Cough Congestionphenylephrine hcl, dextromethorphan hbr, guaifenesinDextromethorphan hydrobromide 10 mg/15mL + 2 more ingredientsLiquidOralThe Procter & Gamble Manufacturing Company69423-982

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