Allergy

Product NDC: 55910-124
11-digit product format: 559100124
Labeler code: 55910
Product ID: 55910-124_12854de7-f633-499b-b703-4f3a695562d4
Type: HUMAN OTC DRUG
Nonproprietary name: Diphenhydramine HCl
Dosage form: SOLUTION
Route: ORAL
Labeler: DOLGENCORP, LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2024-06-06
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
218c447e-9ddd-428a-9b33-0acec35e0d1b	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
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
3e48c9c4-918d-5d23-2f0b-d2398b06be54	Product name	1	20140508
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
865c72dd-0d94-daac-f728-ddd4ded2a79e	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55910-124-36	AllergyChildrens	1 in 1 CARTON	SOLUTION	1		4
55910-124-36	AllergyChildrens	118 mL in 1 BOTTLE, PLASTIC	SOLUTION	118		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55910-124	ALLERGY CHILDRENS (DIPHENHYDRAMINE HCL) SOLUTION [DOLGENCORP, LLC]	3	Current NDC, 2 package rows	20240622_218c447e-9ddd-428a-9b33-0acec35e0d1b.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 48 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NIGHTTIME CHERRY COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE	BETTER LIVING BRANDS LLC.	36924420-f514-4225-e063-6294a90a330c	2026-03-03	Warnings	Exact identifier application number: M012
Daytime Nighttime Ultra Concentrated	DAYTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND NIGHTTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	CVS HEALTH CORP	4584d701-5a4e-e54e-e063-6394a90a38d6	2026-03-03	Warnings	Exact identifier application number: M012
foster and thrive nighttime cold and flu relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Sportpharm LLC	7bdfd2ef-bb99-41f5-97ae-3a02c994bddd	2026-03-03	Warnings	Exact identifier application number: M012
Medique at Home Decorel Forte	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Sportpharm LLC	d27b5976-8cc0-4d99-96f6-9069b786affd	2026-03-03	Warnings	Exact identifier application number: M012
Tusnel EX	GUAIFENESIN	A-S Medication Solutions	7f703c9c-2256-4524-9d31-c51919399d26	2026-03-03	Warnings	Exact identifier application number: M012
Cough Relief	DEXTROMETHORPHAN HBR	Best Choice (Valu Merchandisers Company)	f49f1e9a-07ac-443e-9df8-3281d5f35e78	2026-03-03	Warnings	Exact identifier application number: M012
berkley and jensen nasal	OXYMETAZOLINE HYDROCHLORIDE	BJWC	77cbe75d-4ed9-4a8b-91dc-1cc28af25508	2026-03-02	Warnings	Exact identifier application number: M012
childrens cold and cough relief dm	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE	Walgreen Company	6c7c950d-ed48-4428-9e9e-73684cabc699	2026-02-28	Warnings	Exact identifier application number: M012
Chest Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	The Kroger Co.	116146db-719f-4c48-8a8a-1120ea62b0d5	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	BIONPHARMA INC.	1f737b76-14b5-618a-e063-6294a90a19c2	2026-02-27	Warnings	Exact identifier application number: M012
WALGREENS NIGHTTIME ALLERGY RELIEF	DOXYLAMINE SUCCINATE	WALGREENS CO.	a3c7df98-4611-4b61-9c03-5e687364bf74	2026-02-27	Warnings	Exact identifier application number: M012
MEIJER Childrens Allergy Relief Chews	DIPHENHYDRAMINE HCL	MEIJER DISTRIBUTION INC	3368e081-a3b2-4c03-8bd1-05cc6af0391d	2026-02-27	Warnings	Exact identifier application number: M012
CVS PHARMACY Nighttime MS Flu Relief	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND DEXTROMETHOPHAN HBR	CVS PHARMACY	23cafaa1-34fe-4cef-960b-5f664ea32cb4	2026-02-27	Warnings	Exact identifier application number: M012
Tussin DM Cough and Chest	DEXTROMETHORPHAN HBR, GUAIFENESIN	WinCo Foods, LLC	402969c9-945c-44b7-b018-b62f427ce571	2026-02-26	Warnings	Exact identifier application number: M012
nasal original	OXYMETAZOLINE HYDROCHLORIDE	HyVee Inc	d997f264-1b4a-4cca-a282-bd9645d55bfd	2026-02-26	Warnings	Exact identifier application number: M012
Multi-Symptom Cold and Fever Childrens	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	CVS PHARMACY	2a569e47-3f17-4fc7-83d6-a3dddfd4987e	2026-02-25	Warnings	Exact identifier application number: M012
Cough and Chest Congestion DN, Cough DM Daytime, Nighttime	DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	184059b7-9238-480e-be4a-ed105f13c19d	2026-02-25	Warnings	Exact identifier application number: M012
Kids Daytime Cough and Nighttime Cough combo pack	DEXTROMETHORPHAN HBR, GUAIFENESIN, CHLORPHENIRAMINE MALEATE	Genexa Inc.	4bad39f1-86d4-b8a1-e063-6394a90a7a95	2026-02-25	Warnings	Exact identifier application number: M012
dimaphen dm	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Major Pharmaceuticals	67072a38-1ae7-4e59-bfed-71db0d93215d	2026-02-25	Warnings	Exact identifier application number: M012
leader tussin cf	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Cardinal Health 110, LLC. dba Leader	b3e3699b-b36c-453c-8f3b-0001388c8e82	2026-02-25	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	218c447e-9ddd-428a-9b33-0acec35e0d1b	4
1049906	diphenhydramine hydrochloride 2.5 MG/ML Oral Solution	SCD	218c447e-9ddd-428a-9b33-0acec35e0d1b	4
1049906	diphenhydramine HCl 12.5 MG per 5 ML Oral Solution	SY	218c447e-9ddd-428a-9b33-0acec35e0d1b	4
1049906	diphenhydramine hydrochloride 25 MG per 10 ML Oral Solution	SY	218c447e-9ddd-428a-9b33-0acec35e0d1b	4
1049906	diphenhydramine hydrochloride 50 MG per 20 ML Oral Solution	SY	218c447e-9ddd-428a-9b33-0acec35e0d1b	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
55910-124-36	55910012436	1 BOTTLE, PLASTIC in 1 CARTON (55910-124-36) / 118 mL in 1 BOTTLE, PLASTIC	2024-06-06	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dollar General 44-018	DOLGENCORP, LLC \| LNK International, Inc.	2026-06-17	HUMAN OTC DRUG LABEL	5