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 85 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Maximum Strength Mucus Relief Severe Congestion and Cough	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Wal-Mart Stores,Inc.,	770c0e4f-0eed-4b8c-85a5-761b6a84db62	2025-12-02	Warnings	Exact identifier application number: M012
Multi Symptom Severe Cold and Nighttime Severe Cold and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	WAL-MART STORES INC	a2a7e568-bff8-4818-a31d-7c2efa1859c3	2025-12-02	Warnings	Exact identifier application number: M012
DayTime Severe, Cold and Flu, 24-7 Life by 7-Eleven	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL TABLET, FILM COATED TABLET	Lil' Drug Store Products, Inc.	44fa0193-2a19-bdc1-e063-6394a90a60e8	2025-12-02	Warnings	Exact identifier application number: M012
Nighttime Severe, Cold and Flu, 24-7 Life by 7-Eleven	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL TABLET, FILM COATED	Lil' Drug Store Products, Inc.	44fb9958-d771-f4b3-e063-6294a90a9135	2025-12-02	Warnings	Exact identifier application number: M012
Quality Choice Mucus Relief	GUAIFENESIN	Chain Drug Marketing Association	f1a73da7-0dbb-49bd-857e-7dd6bc11b63c	2025-12-02	Warnings	Exact identifier application number: M012
Cold and Flu Relief Daytime	ACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCL	CARDINAL HEALTH 110, LLC. DBA LEADER 70000	ac74be47-30f0-418b-bd07-502feaa9723f	2025-12-01	Warnings	Exact identifier application number: M012
Walgreens High Blood Pressure Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN	WALGREENS CO.	bc83b55e-c3d8-460f-8ef9-ff7b2e4f7272	2025-12-01	Warnings	Exact identifier application number: M012
Walgreen High Blood Pressure Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE	WALGREENS CO.	f1b7b58f-bbc3-441f-926f-d66e6a9b4e3a	2025-12-01	Warnings	Exact identifier application number: M012
Walgreens Nighttime Kids Honey Cold Cough Congestion	DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	WALGREENS CO	c0f317cd-723d-47f2-b600-aaeae6399482	2025-12-01	Warnings	Exact identifier application number: M012
Walgreen Maximum Strength Severe Congestion and cough	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	WALGREENS CO.	b4abcb6d-f3e1-4d63-98cf-ff556ec423b6	2025-12-01	Warnings	Exact identifier application number: M012
Walgreens Daytime Childrens	COUGH AND CHEST CONGESTION	WALGREENS CO.	dd99675f-3860-42ef-999c-d9a3746a38c0	2025-12-01	Warnings	Exact identifier application number: M012
Adult Cough plus Chest Congestion DM with Honey	DEXTROMETHORPHAN HBR, GUAIFENESIN	WALGREEN COMPANY	5f5af13a-c2a3-4bbe-880e-9c57b36e9234	2025-12-01	Warnings	Exact identifier application number: M012
Walgreens Maximum Strength Severe Congestion and Cough	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	WALGREEN COMPANY	b2e08f4d-9753-4767-a8eb-3740dd1034cc	2025-12-01	Warnings	Exact identifier application number: M012
WALGREENS Cold Cough and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	WALGREENS CO.	1e903034-942e-4c6e-9f96-eb097c266580	2025-12-01	Warnings	Exact identifier application number: M012
Walgreens DAY and NIGHT PACK	DEXTROMETHORPHAN HBR, GUAIFENESIN, CHLORPHENIRAMINE MALEATE	WALGREEN CO	cb87e57b-ff06-4973-9751-137c7021e272	2025-12-01	Warnings	Exact identifier application number: M012
WALGREEN Multi Symptom Flu Relief Combo Pack	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	WALGREENS CO.	b7b1d604-921d-4ae7-93de-dcf690d421b4	2025-12-01	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	Meijer Distribution Inc	235b2866-bbda-7148-e063-6394a90a898f	2025-12-01	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	Whole Foods Market, INC.	32352109-31dc-8e6f-e063-6294a90a2f92	2025-12-01	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	BIONPHARMA INC.	323347c3-d51a-4976-e063-6294a90a952e	2025-12-01	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	WALGREEN COMPANY	2969ba8f-c477-222a-e063-6394a90af703	2025-12-01	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