Childrens Allergy

Product NDC: 63868-370
11-digit product format: 638680370
Labeler code: 63868
Product ID: 63868-370_efac59d9-21aa-4627-876f-12a5fe16165b
Type: HUMAN OTC DRUG
Nonproprietary name: Diphenhydramine Hydrochloride
Dosage form: LIQUID
Route: ORAL
Labeler: QUALITY CHOICE (Chain Drug Marketing Association)
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2014-05-30
Marketing end: 2026-12-28
Substance: DIPHENHYDRAMINE HYDROCHLORIDE
Active strength: 12.5 mg/5mL
Pharmacologic classes: Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag: No
Current FDA listing: Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Childrens Allergy

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIPHENHYDRAMINE HYDROCHLORIDE	12.5 mg/5mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0e2e0f88-b076-afe1-4bdd-32bca4375bec	Product name	3	20250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54	Product name	1	20140508
865c72dd-0d94-daac-f728-ddd4ded2a79e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63868-370-04	Childrens Allergy	1 in 1 BOX	LIQUID	1		7
63868-370-04	Childrens Allergy	118 mL in 1 BOTTLE	LIQUID	118		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63868-370-04	ML - Milliliter	63868-370	33df79f1-77ca-40ba-9508-19cfff3b1f2a	1	2021-04-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DIPHENHYDRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]	1
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]	1
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]	1
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]	1
POLOXAMER 407	INACTIVE INGREDIENT	TUF2IVW3M2	CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]	1
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63868-370	CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]	7	Current NDC, Legacy NDC, 2 package rows	20240423_9bddedbb-40a2-47d3-be35-7b6fce4f755d.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 68 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Equate SF Menthol Cough Drops	MENTHOL	WalMart	003a229c-b014-e9f3-e063-6294a90aa5ed	2025-12-23	Warnings	Exact identifier application number: M012
Equate Menthol Cough Drops	MENTHOL	Walmart	124e6968-f59c-39d4-e063-6294a90a66d4	2025-12-23	Warnings	Exact identifier application number: M012
Equate Severe Menthol Throat Drop	MENTHOL	Walmart	125f3f5a-52aa-e398-e063-6394a90a0012	2025-12-23	Warnings	Exact identifier application number: M012
Equate Menthol Chewable Gels	MENTHOL	Walmart	1ba4b2be-7242-0a23-e063-6294a90af29c	2025-12-23	Warnings	Exact identifier application number: M012
Walgreens Severe Menthol Throat Drops	MENTHOL	Walgreens	21dd3c68-cbc6-4799-e063-6394a90a6972	2025-12-23	Warnings	Exact identifier application number: M012
cherry throat relief lozenges	BENZOCAINE	Zee Medical	499d0748-538f-678c-e054-00144ff8d46c	2025-12-23	Warnings	Exact identifier application number: M012
Guaiasorb DM	DEXTROMETHORPHAN HBR, GUAIFENESIN	NuCare Pharmaceuticals, Inc.	46a480c7-7092-b809-e063-6294a90a60cd	2025-12-23	Warnings	Exact identifier application number: M012
menthol cough drops	MENTHOL	Winco Foods	360a6304-206d-5475-e054-00144ff8d46c	2025-12-23	Warnings	Exact identifier application number: M012
menthol cough drops	MENTHOL	Winco Foods	36342d8c-34ab-6178-e054-00144ff8d46c	2025-12-23	Warnings	Exact identifier application number: M012
cherry cough drops	MENTHOL	Winco Foods	37244333-1307-5121-e054-00144ff8d46c	2025-12-23	Warnings	Exact identifier application number: M012
honey lemon cough drops	MENTHOL	Winco foods	37718c73-880e-4a5c-e054-00144ff8d46c	2025-12-23	Warnings	Exact identifier application number: M012
honey lemon cough drops	MENTHOL	Winco Foods	40676ddc-577f-5cc9-e054-00144ff88e88	2025-12-23	Warnings	Exact identifier application number: M012
Sugar Free Menthol Cough Drops	MENTHOL	Winco Foods	3788e8b6-ab9e-1513-e054-00144ff88e88	2025-12-23	Warnings	Exact identifier application number: M012
SAFETUSSIN Non Drowsy Cough plus chest congestion	DEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESIN	KRAMER LABORATORIES	eeca6370-29ea-4540-8139-e8461d58a286	2025-12-23	Warnings	Exact identifier application number: M012
Tussin DM	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Discount Drug Mart	dd31f86b-f59e-459a-8e5f-176828706a4a	2025-12-23	Warnings	Exact identifier application number: M012
Tussin CF	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Discount Drug Mart	f8e7a08e-7422-4a1b-bfec-93e0b50d10cd	2025-12-23	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL 25 MG	Pioneer Life Sciences, LLC	ab45ae97-7951-4058-e053-2995a90a7b2e	2025-12-23	Warnings	Exact identifier application number: M012
Childrens Chest Congestion Relief Grape	GUAIFENESIN	Discount Drug Mart	3e5d245f-515c-4106-a855-fb97681b646a	2025-12-23	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL 25 MG	Pioneer Life Sciences, LLC	ab45ed16-86bb-3faf-e053-2995a90acfbc	2025-12-23	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL 25 MG	Pioneer Life Sciences, LLC	a7999da7-148a-4c6d-a2ea-0f4cc1d5b283	2025-12-23	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
TC2D6JAD40	DIPHENHYDRAMINE HYDROCHLORIDE	147-24-0	DIPHENHYDRAMINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1049906	diphenhydrAMINE HCl 12.5 MG in 5 mL Oral Solution	PSN	9bddedbb-40a2-47d3-be35-7b6fce4f755d	7
1049906	diphenhydramine hydrochloride 2.5 MG/ML Oral Solution	SCD	9bddedbb-40a2-47d3-be35-7b6fce4f755d	7
1049906	diphenhydramine HCl 12.5 MG per 5 ML Oral Solution	SY	9bddedbb-40a2-47d3-be35-7b6fce4f755d	7
1049906	diphenhydramine hydrochloride 25 MG per 10 ML Oral Solution	SY	9bddedbb-40a2-47d3-be35-7b6fce4f755d	7
1049906	diphenhydramine hydrochloride 50 MG per 20 ML Oral Solution	SY	9bddedbb-40a2-47d3-be35-7b6fce4f755d	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63868-370-04	63868037004	1 BOTTLE in 1 BOX (63868-370-04) / 118 mL in 1 BOTTLE	1 bottle	2014-05-30	2026-12-28	No	No	Current