CVS dye-free childrens allergy

Product NDC: 51316-710
11-digit product format: 513160710
Labeler code: 51316
Product ID: 51316-710_483f1ed8-8525-4f47-a6c7-01bb4f8fc338
Type: HUMAN OTC DRUG
Nonproprietary name: Diphenhydramine hydrochloride
Dosage form: SYRUP
Route: ORAL
Labeler: CVS PHARMACY
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2022-07-22
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: CVS dye-free childrens allergy
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
db5a5eff-1bb1-4d00-8c01-caae7a1c7223	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
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
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
51316-710-08	CVS dye-free childrens allergy	1 in 1 CARTON	SYRUP	1		5
51316-710-08	CVS dye-free childrens allergy	236 mL in 1 BOTTLE, PLASTIC	SYRUP	236		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51316-710	CVS DYE-FREE CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) SYRUP [CVS PHARMACY]	4	Current NDC, Legacy NDC, 2 package rows	20240822_db5a5eff-1bb1-4d00-8c01-caae7a1c7223.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 117 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Severe Cold	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	United Natural Foods, Inc. dba UNFI	cf2dd1fb-1d5b-428e-8c9a-a46dbd7cb645	2025-05-07	Warnings	Exact identifier application number: M012
Theraflu Severe Cold Relief Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	Haleon US Holdings LLC	2b962d87-6ff5-4c0f-8504-e5b61c940612	2025-05-05	Warnings	Exact identifier application number: M012
Cough and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE LIQUID	CVS	2d13564a-e8d1-c357-e063-6394a90ad90e	2025-05-02	Warnings	Exact identifier application number: M012
SUDAFED OM Sinus Severe No Drip Nasal Mist with Cooling Menthol	OXYMETAZOLINE HYDROCHLORIDE	Kenvue Brands LLC	33fe0e49-3de5-8afd-e063-6294a90a0ad5	2025-05-02	Warnings	Exact identifier application number: M012
Daytime and Nighttime High Blood Pressure Cold and Flu Liquid	ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	CVS Pharmacy, Inc.	2d13964a-8cc4-f3dc-e063-6394a90aa105	2025-05-02	Warnings	Exact identifier application number: M012
DIPHENHYDRAMINE HCL 12.5 MG PER 5 ML	DIPHENHYDRAMINE HCL 12.5 MG PER 5 ML	AARNA USA INC.	32c26835-f54e-d7e5-e063-6294a90ae1c0	2025-04-30	Warnings	Exact identifier application number: M012
SUDAFED OM Sinus Severe No Drip Nasal Mist	OXYMETAZOLINE HYDROCHLORIDE	Kenvue Brands LLC	33e6239b-364a-0e62-e063-6294a90a5047	2025-04-29	Warnings	Exact identifier application number: M012
Childrens Allergy Relief	DIPHENHYDRAMINE HCL	CVS Pharmacy	8296049c-72fc-4200-9d45-c8e377314cf2	2025-04-29	Warnings	Exact identifier application number: M012
NIGHTTIME COLD AND FLU RELIEF	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATE	Aurohealth LLC	70e1bd25-c32e-491f-b383-91d6f74957a0	2025-04-28	Warnings	Exact identifier application number: M012
Childrens Allergy Relief Dye Free	DIPHENHYDRAMINE HCL	CVS Pharmacy	70914691-220c-4fce-9ee1-61a51e8864bc	2025-04-26	Warnings	Exact identifier application number: M012
Pseudoephedrine Hydrochloride	PSEUDOEPHEDRINE HYDROCHLORIDE	A-S Medication Solutions	810ce630-41be-4e15-b64a-d70f63abaf62	2025-04-24	Warnings	Exact identifier application number: M012
nasal	OXYMETAZOLINE HYDROCHLORIDE	H E B	5f945975-224f-43eb-b129-a61e3b25c4bb	2025-04-22	Warnings	Exact identifier application number: M012
Walgreens Severe Honey Lemon Throat Drops	MENTHOL	Walgreens	334a9348-2a44-5c94-e063-6394a90ae956	2025-04-21	Warnings	Exact identifier application number: M012
meijer Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Meijer, Inc.	1bd85bc3-e600-583d-e063-6294a90a7be1	2025-04-18	Warnings	Exact identifier application number: M012
Daytime Nighttime Ultra Concentrated	DAYTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND NIGHTTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	KROGER COMPANY	2be4a37b-44e1-8a8e-e063-6394a90a26a9	2025-04-17	Warnings	Exact identifier application number: M012
good neighbor pharmacy childrens cold and cough	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE	Amerisource Bergen	cde0fd43-771f-4528-bad2-5727efec5250	2025-04-17	Warnings	Exact identifier application number: M012
MUCUS RELIEF	GUAIFENESIN 400 MG	Pioneer Life Sciences, LLC	729ab412-f30b-4ad1-9d8f-1a5e1c48b118	2025-04-16	Warnings	Exact identifier application number: M012
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	9382c976-3067-4923-a38f-101d1c481e97	2025-04-11	Warnings	Exact identifier application number: M012
Daytime Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE AND PHENYLEPHRINE HCL LIQUID FILLED CAPSULES	Walmart Inc.	263d31c8-bdc2-a289-e063-6394a90a4aaa	2025-04-10	Warnings	Exact identifier application number: M012
CVS Wild Cherry Throat Drop	PECTIN	CVS	31f4b641-e9c0-786e-e063-6394a90aa253	2025-04-04	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	db5a5eff-1bb1-4d00-8c01-caae7a1c7223	5
1049906	diphenhydramine hydrochloride 2.5 MG/ML Oral Solution	SCD	db5a5eff-1bb1-4d00-8c01-caae7a1c7223	5
1049906	diphenhydramine HCl 12.5 MG per 5 ML Oral Solution	SY	db5a5eff-1bb1-4d00-8c01-caae7a1c7223	5
1049906	diphenhydramine hydrochloride 25 MG per 10 ML Oral Solution	SY	db5a5eff-1bb1-4d00-8c01-caae7a1c7223	5
1049906	diphenhydramine hydrochloride 50 MG per 20 ML Oral Solution	SY	db5a5eff-1bb1-4d00-8c01-caae7a1c7223	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
51316-710-08	51316071008	1 BOTTLE, PLASTIC in 1 CARTON (51316-710-08) / 236 mL in 1 BOTTLE, PLASTIC	2022-07-22	0000-00-00	No	No	Current