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 133 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tenalif Multi Symptom Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	OPMX LLC	05cd94e7-1808-3bb3-e063-6294a90a4140	2024-12-03	Warnings	Exact identifier application number: M012
Nasal Decongestant PE and Pain Relief Plus Mucus Relief	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Winco Foods, LLC	31531f90-8933-46ab-b722-cb63e7738639	2024-12-03	Warnings	Exact identifier application number: M012
Mucus Relief Sinus Pressure Pain and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	WINCO FOODS, LLC	f45f3ab4-5e10-3004-e053-2a95a90a0cb4	2024-12-03	Warnings	Exact identifier application number: M012
good sense allergy	DIPHENHYDRAMINE HCL	NuCare Pharmaceuticals, Inc.	2861b801-e778-822d-e063-6394a90aa1a8	2024-12-03	Warnings	Exact identifier application number: M012
Sinus plus Headache	ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION INC	fe0cf681-f42c-430c-8429-f7ba4bc5a976	2024-12-02	Warnings	Exact identifier application number: M012
Allergy Multisymptom	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION INC	5a5aa2ee-51b7-4698-bb27-3fb9d01bbea5	2024-12-02	Warnings	Exact identifier application number: M012
Mucus Relief Sinus Severe Congestion Relief	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Chain Drug Marketing Association	0ea270b7-9c28-49fb-9615-c4afdbdbc8f1	2024-12-02	Warnings	Exact identifier application number: M012
Head Congestion Mucus PE	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION INC	0955d856-cc4e-4ef2-8bc0-1a632a5b5f79	2024-12-02	Warnings	Exact identifier application number: M012
Head Congestion Flu Severe PE	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION INC	40c9c90d-6c9e-40d0-921d-1fd34eff90bb	2024-12-02	Warnings	Exact identifier application number: M012
Mucus Relief Sinus Pressure Pain and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION INC	3d068d30-9a00-49d7-bbe9-d6b53c19e86d	2024-12-02	Warnings	Exact identifier application number: M012
Diphenhydramine	DIPHENHYDRAMINE HYDROCHLORIDE	AAA Pharmaceutical, Inc.	76724432-ff3c-404f-ba1f-5af68e3ab8c4	2024-12-02	Warnings	Exact identifier application number: M012
Sinus and Headache	ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE	AAA Pharmaceutical, Inc.	73d4fc82-8508-44f8-83ca-9f32c5cd847b	2024-12-02	Warnings	Exact identifier application number: M012
Allergy Multi Symptom	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE	AAA PHARMACEUTICAL, INC.	19898135-0f7b-45a5-a672-14c49fd21077	2024-12-02	Warnings	Exact identifier application number: M012
MUCUS RELIEF	GUAIFENESIN	Geri-Care Pharmaceuticals, Corp	bb72de5d-d3c0-42fc-ae52-a3ad95214af5	2024-12-02	Warnings	Exact identifier application number: M012
Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	AAA Pharmaceutical, Inc.	a242e005-0330-4afb-83b8-13c7d56f5c6d	2024-12-02	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	TopCo Associates LLC	53b15e75-9efd-4b4b-834b-6e9f12c60108	2024-12-02	Warnings	Exact identifier application number: M012
Geri-Dryl allergy relief	DIPHENHYDRAMINE HCL	Geri-Care Pharmaceutical Corp	ac8a14ac-7023-1e23-e053-2995a90aea3a	2024-11-28	Warnings	Exact identifier application number: M012
Childrens Benadryl DYE-FREE ALLERGY	DIPHENHYDRAMINE HYDROCHLORIDE	Kenvue Brands LLC	10d478ff-ddc6-45da-87ff-cfe1b2b07a8e	2024-11-27	Warnings	Exact identifier application number: M012
M-Dryl	DIPHENHYDRAMINE HYDROCHLORIDE	Bryant Ranch Prepack	9cd10af6-a2fa-44f8-8df3-a6d2a95a5293	2024-11-27	Warnings	Exact identifier application number: M012
Severe Sinus Congestion Allergy and Cough Formula	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE , DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	PuraCap Pharmaceutical LLC	36a4ec1f-50c3-4d61-ada9-987ccad3563c	2024-11-26	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