Over-the-counter drug · OTC MONOGRAPH DRUG

Childrens Allergy (Diphenhydramine hydrochloride) NDC 63868-370

Diphenhydramine hydrochloride 12.5 mg/5mL · Liquid · Oral · QUALITY CHOICE (Chain Drug Marketing Association)

NDC codes

FDA NDC Directory
Product NDC (as listed)63868-370Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63868-0370Add 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
63868-370-0463868037004638680370041 BOTTLE in 1 BOX (63868-370-04) / 118 mL in 1 BOTTLEMarketed from May 30, 2014

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
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication M 012
Marketing start
Marketing end
Other FDA classes
Histamine H1 Receptor Antagonists (Mechanism)
Identifiers
Product ID 63868-370_efac59d9-21aa-4627-876f-12a5fe16165bSPL ID efac59d9-21aa-4627-876f-12a5fe16165b
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

N463868037004 followed by a unit qualifier and the quantity

Package 63868-0370-04. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 63868-370

What is NDC 63868-370?
63868-370 is the product NDC for Childrens Allergy (diphenhydramine hydrochloride), Diphenhydramine hydrochloride 12.5 mg/5mL liquid, listed with the FDA by QUALITY CHOICE (Chain Drug Marketing Association). 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?
QUALITY CHOICE (Chain Drug Marketing Association), NDC labeler code 63868. 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 Allergydiphenhydramine hydrochlorideDiphenhydramine hydrochloride 12.5 mg/5mLLiquidOralAptaPharma Inc.76281-50576281-0505-24
Childrens Allergyfexofenadine hclFexofenadine hydrochloride 30 mg/5mLSuspensionOralEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)49035-20849035-0208-04

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
Cough Reliefdextromethorphan hydrobromideDextromethorphan hydrobromide 15 mg/1Capsule, Liquid filledOralAdvanced Rx LLC80513-311
TARGET Multi Symptom Flu Reliefacetaminophen, dextromethorphan hbr, and acetaminophen, chlorpheniramine maleate, dextromethorphan hbr—KitTARGET CORPORATION82442-559
Geri-Dryl allergy reliefdiphenhydramine hclDiphenhydramine hydrochloride 25 mg/1Tablet, CoatedOralVerityRx83939-0683
Multi Symptom Cold and Multi Symptom Nighttime Cold Childrensdextromethorphan hbr, guaifenesin, phenylephrine hci, acetaminophen, diphenhydramine hci, phenylephrine hci—KitTARGET Corporation11673-420
Welmedix HomeCare PRO Extra Strength Rapid Rash Reliefpetrolatum, zinc oxidePetrolatum 49 g/100g; Zinc oxide 15 g/100gCreamTopicalWelmedix LLC24330-410
topcare nite time cold and fluacetaminophen, dextromethorphan hbr, doxylamine succinateAcetaminophen 325 mg/1 + 2 more ingredientsCapsule, Liquid filledOralTopco Associates LLC36800-143
Allergy Childrensdiphenhydramine hydrochlorideDiphenhydramine hydrochloride 12.5 mg/5mLLiquidOralH E B37808-012
Mucus Relief Cough Childrensdextromethorphan hbr, guaifensinDextromethorphan hydrobromide 5 mg/5mL; Guaifenesin 100 mg/5mLLiquidOralH E B37808-594
Sunmark Chest Congestion Relief DM DMdextromethorphan hydrobromide / guaifenesinDextromethorphan hydrobromide 20 mg/1; Guaifenesin 400 mg/1TabletOralStrategic Sourcing Services LLC49348-728
Dual Action Honey Lemon Cough Suppressant Oral AnestheticmentholMenthol 8.3 mg/1LozengeOralRicola Ag54305-323
Discount drug mart Extra Moisturizingoxymetazoline hydrochlorideOxymetazoline hydrochloride .05 g/100mLSprayNasalDISCOUNT DRUG MART53943-720
Mucus ReliefguaifenesinGuaifenesin 400 mg/1TabletOralGeri-Care Pharmaceuticals, Corp57896-714
Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu Nighttimeacetaminophen, diphenhydramine hclAcetaminophen 650 mg/20mL; Diphenhydramine hydrochloride 25 mg/20mLLiquidOralHaleon US Holdings LLC0031-0101
Throat Comfort Orange Mint Cinnamon DropsmentholMenthol 3.6 mg/1LozengeOralRicola USA Inc.63667-342
Non-Drowsy Sinus Severe, Circle Kacetaminophen, guaifenesin, phenylephrine hcl caplet, film-coatedGuaifenesin 200 mg/1 + 2 more ingredientsTablet, Film coatedOralLil' Drug Store products, Inc.66715-5632
COLD, Flu and Sore Throatacetaminophen, guaifenesin, dextromethorphan hydrobromide, and phenylephrine hydrochlorideAcetaminophen 325 mg/1 + 3 more ingredientsCapsule, Liquid filledOralWalgreens0363-9016
Mucus Relief All in One Maximum Strengthacetaminophen, diphenhydramine hcl phenylephrine hclAcetaminophen 650 mg/20mL + 2 more ingredientsLiquidOralWalgreens0363-9130
Pyrilamine Maleate and Dextromethorphan HydrobromideDextromethorphan hydrobromide 7.5 mg/5mL; Pyrilamine maleate 7.5 mg/5mLLiquidOralWestminster Pharmaceuticals, LLC69367-398
Daytime Cold and Flu Relief Liquid Filled Softgelsacetaminophen, dextromethorphan hbr, phenylephrine hclAcetaminophen 325 mg/1 + 2 more ingredientsCapsule, Liquid filledOralAptaPharma Inc.76281-604
Cough DropsmentholMenthol 5.8 mg/1PastilleOralTopco Associates LLC76162-016

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