Over-the-counter drug · OTC MONOGRAPH DRUG

Childrens Allergy (Diphenhydramine hydrochloride) NDC 76281-505

Diphenhydramine hydrochloride 12.5 mg/5mL · Liquid · Oral · AptaPharma Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)76281-505Labeler and product segments. Claims need a package NDC.
Product NDC at billing width76281-0505Add 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
76281-505-247628105052476281050524118 mL in 1 BOTTLE (76281-505-24)Marketed from Sep 30, 2020

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)
Childrens Allergy
Generic name (nonproprietary)
diphenhydramine hydrochloride
Active ingredients
Diphenhydramine hydrochloride — 12.5 mg/5mL
Dosage form
Liquid
Route
Oral
Labeler
AptaPharma Inc.NDC labeler code 76281
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 76281-505_46e2e387-098c-8f8f-e063-6294a90add68SPL ID 46e2e387-098c-8f8f-e063-6294a90add68SPL set ID b2cef61f-ab54-4a20-a7f7-6d3da4754e8bRxCUI 1049906UNII 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

N476281050524 followed by a unit qualifier and the quantity

Package 76281-0505-24. 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 respiratory allergies: ■ sneezing ■ itching of the nose or throat ■ runny nose ■ itchy watery eyes ■ temporarily relieves these symptoms due to the common cold: ■ sneezing ■ runny nose

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 76281-505

What is NDC 76281-505?
76281-505 is the product NDC for Childrens Allergy (diphenhydramine hydrochloride), Diphenhydramine hydrochloride 12.5 mg/5mL liquid, listed with the FDA by AptaPharma Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Childrens Allergy (Diphenhydramine hydrochloride).
What is the active ingredient?
Diphenhydramine hydrochloride.
Who is the labeler?
AptaPharma Inc., NDC labeler code 76281. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Childrens Allergy?
25 other product NDCs are listed under this name. See all Childrens Allergy 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 Childrens Allergy NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Childrens Allergyfluticasone propionateFluticasone propionate 50 ug/1Spray, MeteredNasalCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED51316-19751316-0197-08
Childrens Allergyfexofenadine hclFexofenadine hydrochloride 30 mg/5mLSuspensionOralWALMART INC. (see also Equate)79903-24979903-0249-04
Childrens Allergyfexofenadine hclFexofenadine hydrochloride 30 mg/5mLSuspensionOralCVS PHARMACY, INC51316-26051316-0260-04
Childrens Allergyfexofenadine hclFexofenadine hydrochloride 30 mg/5mLSuspensionOralFamily Dollar (FAMILY WELLNESS)55319-92355319-0923-04
Childrens Allergydiphenhydramine hydrochlorideDiphenhydramine hydrochloride 12.5 mg/5mLLiquidOralKinderFarms, LLC82673-10982673-0109-04
Childrens Allergyfexofenadine hydrochlorideFexofenadine hydrochloride 30 mg/5mLSuspensionOralH2-Pharma, LLC61269-52761269-0527-94
Childrens Allergydiphenhydramine hclDiphenhydramine hydrochloride 12.5 mg/5mLSolutionOralGenexa Inc.69676-007469676-0074-09
Childrens Allergyfexofenadine hclFexofenadine hydrochloride 30 mg/5mLSuspensionOralH E B37808-62337808-0623-04
Childrens Allergyfexofenadine hclFexofenadine hydrochloride 30 mg/5mLSuspensionOralEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)49035-20849035-0208-04
childrens allergydiphenhydramine hydrochlorideDiphenhydramine hydrochloride 12.5 mg/5mLSolutionOralKroger Company30142-65130142-0651-2630142-0651-34

All 26 Childrens Allergy 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
ProductStrengthForm · routeLabelerProduct NDC
Daytime Cold and Flu Reliefacetaminohpen, dextromethorphan hbr, guaifenesin phenylephrine hclAcetaminophen 650 mg/30mL + 3 more ingredientsLiquidOralThe Kroger Co.30142-722
Cold Fluacetaminophen, dextromethorphan hydrobromide, doxylamine succinate—KitHyVee Inc42507-598
Allergy Reliefdiphenhydramine hclDiphenhydramine hydrochloride 25 mg/1Tablet, Film coatedOralH E B37808-932
Medi First Plus Cherry Cough DropsmentholMenthol 7.6 mg/1LozengeOralUnifirst First Aid Corporation47682-915
Supress Adexbromopheniramine maleate, dextromethorphan hbr, phenylephrine hclDexbrompheniramine maleate 1 mg/mL + 2 more ingredientsSyrupOralKramer Novis52083-057
SAFETUSSIN Non Drowsy Cough plus chest congestiondextromethorphan hydrobromide, and guaifenesinDextromethorphan hydrobromide 10 mg/1; Guaifenesin 200 mg/1TabletOralKRAMER LABORATORIES55505-231
Tusnel-DM Pediatricdextromethorphan hbr, guaifenesin, phenylephrine hclDextromethorphan hydrobromide 2.5 mg/mL + 2 more ingredientsSolution/ dropsOralLLORENS PHARMACEUTICALS INTERNATIONAL DIVISION54859-606
Dg Health Cold Flu Reliefacetaminophen, dextromethorphan hydrobromide, doxylamine succinateAcetaminophen 325 mg/15mL + 2 more ingredientsSolutionOralDolgencorp Inc55910-753
Acetaminophen and Diphenhydramine citrateAcetaminophen 500 mg/1; Diphenhydramine citrate 38 mg/1TabletOralInvaTech Pharma Solutions LLC57631-010
MUCINEX SINUS-MAX SEVERE CONGESTION RELIEF SINUS and ALLERGYoxymetazoline hydrochlorideOxymetazoline hydrochloride .05 g/100mLSolutionNasalReckitt Benckiser LLC63824-120
Vicks Sinex SEVERE CONGESTIONoxymetazoline hydrochlorideOxymetazoline hydrochloride .0005 g/mLSprayNasalProcter & Gamble Manufacturing GmbH64336-002
Walgreens Honey Lemon Cough DropsmentholMenthol 7.5 mg/1LozengeOralWalgreens0363-9959
Tesalon Jarabe Adultoacetaminophen, dextromethorphan hbr, guaifenesin usp, phenylephrine hclAcetaminophen 500 mg/20mL + 3 more ingredientsSyrupOralOPMX LLC69729-787
GuaifenesinGuaifenesin 400 mg/1TabletOralBryant Ranch Prepack71335-9616
Cold Head Congestion Severeacetaminophen, guaifenesin, and phenylephrine hydrochlorideAcetaminophen 325 mg/1 + 2 more ingredientsTablet, CoatedOralHarris Teeter72036-175
DG Health Cough Drops Cherry FlavormentholMenthol 5.8 mg/1LozengeTopicalDollar General Corporation75712-005
Nuvicare NightTime Cold and Flu Softgelacetaminophen, dextromethorphan hydrobromide, doxylamine succinateAcetaminophen 325 mg/1 + 2 more ingredientsCapsule, Liquid filledOralNUVICARE LLC84324-019
Quality Choice Mucus ReliefguaifenesinGuaifenesin 400 mg/1TabletOralChain Drug Marketing Association83324-194
Diphenhydramine HClDiphenhydramine hydrochloride 12.5 mg/5mLSolutionOralMajor Pharmaceuticals0904-6985
severe cold and flu reliefacetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochlorideAcetaminophen 325 mg/15mL + 3 more ingredientsSolutionOralRite Aid Corporation11822-3120

Showing 20 of 40.

Med-Code uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. Med-Code is free: log in or create a free profile to keep looking up NDCs, J-codes and drugs.

Create a free profileLog in