CVS Childrens Nighttime Multi Symptom Cold

Product NDC: 51316-733
11-digit product format: 513160733
Labeler code: 51316
Product ID: 51316-733_e1d05e87-3e21-4047-a40e-99af2d87282d
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen , Diphenhydramine Hydrochloride,Phenylephrine Hydrochloride
Dosage form: LIQUID
Route: ORAL
Labeler: CVS PHARMACY
Application: M010
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2023-02-20
Substance: ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength: 325; 12.5; 5 mg/10mL; mg/10mL; mg/10mL
Pharmacologic classes: Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [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 Childrens Nighttime Multi Symptom Cold
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	325 mg/10mL
DIPHENHYDRAMINE HYDROCHLORIDE	12.5 mg/10mL
PHENYLEPHRINE HYDROCHLORIDE	5 mg/10mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
362O9ITL9D	Internal UNII lookup
TC2D6JAD40	Internal UNII lookup
04JA59TNSJ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1375932	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
9b244ac8-4ca7-43a0-b328-88f15f0fcc9d	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e4e263da-1c53-440f-bb80-b7a575843b5a	Product name	1	20260313
d2168cac-a261-415a-9c78-3522859fa720	Product name	3	20251124
05a8cdd1-eeb8-409e-b938-0778225eca7d	Product name	4	20250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9	Product name	8	20250220
0e2e0f88-b076-afe1-4bdd-32bca4375bec	Product name	3	20250127
f489e8f3-5c9e-4818-b539-a73587edcfc7	Product name	2	20240229
0f7ae452-206d-4fc4-868d-56fc47074084	Product name	1	20231011
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
b5abe2e3-39a1-43eb-9bff-f3c1653fe3df	Product name	2	20190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814	Product name	3	20150910
3e48c9c4-918d-5d23-2f0b-d2398b06be54	Product name	1	20140508
42f3c020-f1b3-89bc-7bdc-e1f10e680485	Product name	1	20140508
865c72dd-0d94-daac-f728-ddd4ded2a79e	Product name	1	20140508
e949165d-714d-e548-2b76-0cb5def16f30	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
51316-733-04	CVS Childrens Nighttime Multi Symptom Cold	118 mL in 1 BOTTLE	LIQUID	118		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51316-733	CVS CHILDRENS NIGHTTIME MULTI SYMPTOM COLD (ACETAMINOPHEN , DIPHENHYDRAMINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE) LIQUID [CVS PHARMACY]	4	Current NDC, 1 package rows	20240822_9b244ac8-4ca7-43a0-b328-88f15f0fcc9d.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 6 of 12 · 236 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Unisom SleepMelts Nighttime Sleep-Aid	DIPHENHYDRAMINE HYDROCHLORIDE	QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)	f50cc038-0973-4c4b-84a7-1c68f41c2410	2025-12-04	Warnings	Exact identifier application number: M010
Walgreens Childrens	NIGHTTIME COUGH	WALGREENS CO.	a270cbe3-bf0a-44da-9359-00e218eba239	2025-12-01	Warnings	Exact identifier application number: M010
ZzzQuil ULTRA, Travel BASIX	DOXYLAMINE SUCCINATE	Lil' Drug Store Products, Inc.	0f8c7219-7b40-27c6-e063-6294a90a27d9	2025-12-01	Warnings	Exact identifier application number: M010
Nighttime Sleep-Aid	DIPHENHYDRAMINE HCL	BIONPHARMA INC.	141b00b7-a283-40ab-e063-6294a90aec77	2025-12-01	Warnings	Exact identifier application number: M010
Nighttime Sleep-Aid	DIPHENHYDRAMINE HCL	BIONPHARMA INC.	1f74e760-9ba9-ac47-e063-6394a90acdff	2025-12-01	Warnings	Exact identifier application number: M010
Nighttime Sleep-Aid	DIPHENHYDRAMINE HCL	DISCOUNT DRUG MART, INC.	116e8192-0c2f-39ed-e063-6294a90abaf3	2025-12-01	Warnings	Exact identifier application number: M010
Nighttime Sleep-Aid	DIPHENHYDRAMINE HCL	AMERISOURCE BERGEN	16b2edd2-c16b-5713-e063-6394a90acf46	2025-12-01	Warnings	Exact identifier application number: M010
Nighttime Sleep-Aid	DIPHENHYDRAMINE HCL	VALU MERCHANDISERS COMPANY	08a38cd2-04ae-1ef9-e063-6294a90a8868	2025-12-01	Warnings	Exact identifier application number: M010
Nighttime Sleep-Aid	DIPHENHYDRAMINE HCL	KROGER COMPANY	0f2c1c6a-29bc-e4a8-e063-6394a90a28cb	2025-12-01	Warnings	Exact identifier application number: M010
Nighttime Sleep-Aid	DIPHENHYDRAMINE HCL	Whole Foods Market, INC.	35acf7d9-e567-996d-e063-6394a90a1cf6	2025-12-01	Warnings	Exact identifier application number: M010
Nighttime Sleep Aid	DIPHENHYDRAMINE HYDROCHLORIDE	WALGREEN COMPANY	048cfa3a-4519-400d-a5ab-ce05c9cc4ec8	2025-11-26	Warnings	Exact identifier application number: M010
Sleep Aid Nighttime	DIPHENHYDRAMINE HCL	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	fe58ce40-ae88-4dc5-9486-e67041f6d852	2025-11-26	Warnings	Exact identifier application number: M010
nighttime sleep aid	DIPHENHYDRAMINE HYDROCHLORIDE	H E B	b72c47a3-cae3-4b98-ae85-e1313b6fd501	2025-11-25	Warnings	Exact identifier application number: M010
Nighttime Wal Flu Severe Cold and Cough	ACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINE	WALGREEN CO.	e88f7777-9987-4e3c-a3d5-3da60f190bfd	2025-11-25	Warnings	Exact identifier application number: M010
Overnight Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL	WALGREENS CO	807e8ace-2901-4c5f-96dc-04c755484b95	2025-11-25	Warnings	Exact identifier application number: M010
Sleep	DIPHENHYDRAMINE HCL	Salado Sales, Inc.	837c02dd-971b-4451-98d8-9c438c9db696	2025-11-24	Warnings	Exact identifier application number: M010
Nighttime SleepAid	DIPHENHYDRAMINE HYDROCHLORIDE	AMERIFOODS TRADING COMPANY	3802d57e-7943-c0c2-e063-6394a90a7580	2025-11-20	Warnings	Exact identifier application number: M010
Sleep-Aid Nighttime	DIPHENHYDRAMINE HCL	CVS PHARMACY	6bd1ad2e-8f47-412d-8620-b149ad90c292	2025-11-17	Warnings	Exact identifier application number: M010
Nighttime Sleep-Aid	DIPHENHYDRAMINE HCL	Rite Aid Corporation	f8d50b4e-735d-4d91-a18d-be3537e46e99	2025-11-15	Warnings	Exact identifier application number: M010
SLEEP AID	DIPHENHYDRAMINE HYDROCHLORIDE	Company name: Topco Associates, LLC	7aec7b1b-39dc-4e99-9f92-d45af0a4a6ec	2025-10-31	Warnings	Exact identifier application number: M010

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN
TC2D6JAD40	DIPHENHYDRAMINE HYDROCHLORIDE	147-24-0	DIPHENHYDRAMINE HYDROCHLORIDE
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1375932	acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG in 20 mL Oral Solution	PSN	9b244ac8-4ca7-43a0-b328-88f15f0fcc9d	5
1375932	acetaminophen 32.5 MG/ML / diphenhydramine hydrochloride 1.25 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution	SCD	9b244ac8-4ca7-43a0-b328-88f15f0fcc9d	5
1375932	acetaminophen 325 MG / diphenhydramine HCl 12.5 MG / phenylephrine HCl 5 MG per 10 ML Oral Solution	SY	9b244ac8-4ca7-43a0-b328-88f15f0fcc9d	5
1375932	acetaminophen 650 MG / diphenhydramine HCl 25 MG / phenylephrine HCl 10 MG per 20 ML Oral Solution	SY	9b244ac8-4ca7-43a0-b328-88f15f0fcc9d	5
1375932	APAP 32.5 MG/ML / Diphenhydramine Hydrochloride 1.25 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML Oral Solution	SY	9b244ac8-4ca7-43a0-b328-88f15f0fcc9d	5
1375932	APAP 325 MG / diphenhydramine hydrochloride 12.5 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral Solution	SY	9b244ac8-4ca7-43a0-b328-88f15f0fcc9d	5
1375932	APAP 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG per 20 ML Oral Solution	SY	9b244ac8-4ca7-43a0-b328-88f15f0fcc9d	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
51316-733-04	51316073304	118 mL in 1 BOTTLE (51316-733-04)	118 ml	2023-02-20	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CVS Children’s Nighttime Multi-Symptoms Cold 4 FL OZ (180 mL)	CVS PHARMACY	2026-08-19	HUMAN OTC DRUG LABEL	6