allergy

Product NDC: 41250-379
11-digit product format: 412500379
Labeler code: 41250
Product ID: 41250-379_0fa13b75-38d3-486d-b12d-4054c9861b06
Type: HUMAN OTC DRUG
Nonproprietary name: Diphenhydramine Hydrochloride
Dosage form: SOLUTION
Route: ORAL
Labeler: Meijer Distribution Inc
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 1987-11-15
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
Listing certified through: 2027-12-31
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: allergy
Brand name suffix: childrens
Listing expiration: 2027-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
TC2D6JAD40	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1049906	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
622b12fa-455c-4432-a9a2-698a929bbd68	Available on FDA.report

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

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
41250-379-26	Meijer Distribution, Inc. Children’s Allergy Liquid Drug Facts
41250-379-26	Meijer Distribution, Inc. Children’s Allergy Liquid Drug Facts
41250-379-34	Meijer Distribution, Inc. Children’s Allergy Liquid Drug Facts
41250-379-34	Meijer Distribution, Inc. Children’s Allergy Liquid Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
41250-379-26	allergychildrens	118 mL in 1 BOTTLE	SOLUTION	118	7
41250-379-26	allergychildrens	1 in 1 CARTON	SOLUTION	1	7
41250-379-34	allergychildrens	1 in 1 CARTON	SOLUTION	1	7
41250-379-34	allergychildrens	237 mL in 1 BOTTLE	SOLUTION	237	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
41250-379-26	ML - Milliliter	41250-379	c5fe9355-0212-47a1-b68e-bb2b50b0c742	1	2012-07-24
41250-379-34	ML - Milliliter	41250-379	24fe83bc-4b83-4539-9705-13a2df19e553	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DIPHENHYDRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	ALLERGY CHILDRENS (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [MEIJER DISTRIBUTION INC]	3
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	ALLERGY CHILDRENS (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [MEIJER DISTRIBUTION INC]	3
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	ALLERGY CHILDRENS (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [MEIJER DISTRIBUTION INC]	3
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	ALLERGY CHILDRENS (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [MEIJER DISTRIBUTION INC]	3
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	ALLERGY CHILDRENS (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [MEIJER DISTRIBUTION INC]	3
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	ALLERGY CHILDRENS (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [MEIJER DISTRIBUTION INC]	3
HIGH FRUCTOSE CORN SYRUP	INACTIVE INGREDIENT	XY6UN3QB6S	ALLERGY CHILDRENS (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [MEIJER DISTRIBUTION INC]	3
POLOXAMER 407	INACTIVE INGREDIENT	TUF2IVW3M2	ALLERGY CHILDRENS (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [MEIJER DISTRIBUTION INC]	3
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	ALLERGY CHILDRENS (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [MEIJER DISTRIBUTION INC]	3
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	ALLERGY CHILDRENS (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [MEIJER DISTRIBUTION INC]	3
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	ALLERGY CHILDRENS (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [MEIJER DISTRIBUTION INC]	3
SORBITOL	INACTIVE INGREDIENT	506T60A25R	ALLERGY CHILDRENS (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [MEIJER DISTRIBUTION INC]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	ALLERGY CHILDRENS (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [MEIJER DISTRIBUTION INC]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
41250-379	ALLERGY CHILDRENS (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [MEIJER DISTRIBUTION INC]	6	Current NDC, Legacy NDC, 4 package rows	20240712_622b12fa-455c-4432-a9a2-698a929bbd68.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 104 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
COLD AND FLU DAYTIME-NIGHTTIME	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	TARGET CORP	9de9fab3-890a-158d-e053-2a95a90af423	2025-09-13	Warnings	Exact identifier application number: M012
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Precision Dose, Inc.	4d0f4f5b-3135-4457-bb8f-ad9d28ca5ea4	2025-09-12	Warnings	Exact identifier application number: M012
Nasal Spray, Circle K	OXYMETAZOLINE HYDROCHLORIDE 0.05% SOLUTION	Lil' Drug Store Products, Inc.	3ea06e88-a2c6-621b-e063-6294a90a1075	2025-09-12	Warnings	Exact identifier application number: M012
Daytime Nighttime Cold Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Harris Teeter, LLC	a0090dc6-0fe5-4ab2-a2cf-6ed19892f363	2025-09-12	Warnings	Exact identifier application number: M012
Multi Symptom Cold and Multi Symptom Nighttime Cold Childrens	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI, ACETAMINOPHEN, DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCI	CVS Pharmacy	ebf2dbb4-96fa-4bf6-9afd-8aa8b5369f2e	2025-09-12	Warnings	Exact identifier application number: M012
Daytime Nighttime Cold Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	FSA Store Inc. (Caring Mills)	8d7bb31b-a47d-4252-a0a7-79d286179fb9	2025-09-12	Warnings	Exact identifier application number: M012
Daytime Nighttime Cold Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Family Dollar (FAMILY WELLNESS)	150e5c3a-7c86-4b66-af30-a376df697401	2025-09-12	Warnings	Exact identifier application number: M012
SEVERE COUGH COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	67f8d405-a2ad-4ade-93b4-9b09a0d81d8e	2025-09-11	Warnings	Exact identifier application number: M012
equate MAXIMUM STRENGTH DAYTIME SEVERE Cold and Flu SOFTGELS	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	WALMART INC.	3862aaa5-2281-e8f9-e063-6294a90a0f7e	2025-09-09	Warnings	Exact identifier application number: M012
McKesson Sugar Free Cough Suppressant Oral Anesthetic	MENTHOL LOZENGE	McKesson Medical-Surgical	e0dfa6ca-b311-25cb-e053-2a95a90a12cc	2025-09-09	Warnings	Exact identifier application number: M012
Medique at Home Decorel Forte	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Unifirst First Aid Corporation	e648f017-9e30-df6c-e053-2995a90adcd0	2025-09-09	Warnings	Exact identifier application number: M012
Medi-First Honey Lemon Cough Drops	MENTHOL 8.6 MG	Unifirst First Aid Corporation	826e1b87-e5a9-8637-e053-2991aa0aded1	2025-09-09	Warnings	Exact identifier application number: M012
Unishield Cherry Cough	MENTHOL	Unishield	b8297bc1-44b2-3de0-e053-2995a90ad01b	2025-09-09	Warnings	Exact identifier application number: M012
McKesson Cough Supressant	MENTHOL	McKesson Medical-Surgical	db5e0490-2ed8-2d53-e053-2a95a90a98f5	2025-09-09	Warnings	Exact identifier application number: M012
Duratuss AC	CODEINE PHOSPHATE, DEXBROMPHENIRAMINE MALEATE	Poly Pharmaceuticals, Inc.	3e5ed178-d5d9-b8d4-e063-6394a90a91db	2025-09-09	Warnings	Exact identifier application number: M012
Rompe Pecho CF	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Efficient Laboratories Inc	96c4dee1-6e66-4442-a7e3-56e874414c17	2025-09-09	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu Lil Drug Store Products	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE	Lil' Drug Store Products, Inc	57c458ed-7987-453b-ab24-bbfa6580f920	2025-09-09	Warnings	Exact identifier application number: M012
equate MAXIMUM STRENGTH NIGHTTIME SEVERE Cold and Flu SOFTGELS	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	WALMART INC.	38637189-d1ee-9405-e063-6394a90ae8b8	2025-09-09	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Walgreens	fd52d8d8-7cd1-4e92-86da-354a1d5213c2	2025-09-08	Warnings	Exact identifier application number: M012
Green Guard Advanced Sinus Relief	ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE	Unifirst First Aid Corporation	e8e5fb21-a7fd-44d1-b9c4-83e949699ca6	2025-09-08	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	622b12fa-455c-4432-a9a2-698a929bbd68	7
1049906	diphenhydramine hydrochloride 2.5 MG/ML Oral Solution	SCD	622b12fa-455c-4432-a9a2-698a929bbd68	7
1049906	diphenhydramine HCl 12.5 MG per 5 ML Oral Solution	SY	622b12fa-455c-4432-a9a2-698a929bbd68	7
1049906	diphenhydramine hydrochloride 25 MG per 10 ML Oral Solution	SY	622b12fa-455c-4432-a9a2-698a929bbd68	7
1049906	diphenhydramine hydrochloride 50 MG per 20 ML Oral Solution	SY	622b12fa-455c-4432-a9a2-698a929bbd68	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
41250-379-26	41250037926	1 BOTTLE in 1 CARTON (41250-379-26) / 118 mL in 1 BOTTLE	1 bottle	1987-11-15	0000-00-00	No	No	Current
41250-379-34	41250037934	1 BOTTLE in 1 CARTON (41250-379-34) / 237 mL in 1 BOTTLE	1 bottle	1995-12-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Meijer Distribution, Inc. Children’s Allergy Liquid Drug Facts	Meijer Distribution Inc	2025-10-24	HUMAN OTC DRUG LABEL	7