TOPCARE

Product NDC: 76162-792
11-digit product format: 761620792
Labeler code: 76162
Product ID: 76162-792_434f84ba-ba81-a4e6-e063-6394a90ae042
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen, Chlorpheniramine Maleate, and Dextromethorphan Hydrobromide
Dosage form: SUSPENSION
Route: ORAL
Labeler: Topco Associates, LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2024-08-12
Substance: CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN
Active strength: 1; 5; 160 mg/5mL; mg/5mL; mg/5mL
Pharmacologic classes: Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
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: TOPCARE
Brand name suffix: Childrens Cold and Cough and Runny Nose
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CHLORPHENIRAMINE MALEATE	1 mg/5mL
DEXTROMETHORPHAN HYDROBROMIDE	5 mg/5mL
ACETAMINOPHEN	160 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
V1Q0O9OJ9Z	Internal UNII lookup
9D2RTI9KYH	Internal UNII lookup
362O9ITL9D	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1086750	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
8931d4ca-c599-49be-87e1-8c0598f38b77	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bf324df6-7127-7deb-def5-2681c136cd03	Product name	3	20250325
43a1ed49-eae2-4840-8075-cb4b33478540	Product name	1	20230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
d17a97fa-387f-690e-d2be-0083ab044a03	Product name	3	20170725
0fdb98e2-b951-a1ce-5715-2b187ba500ef	Product name	4	20170718
c6fba691-a132-4ede-95c6-f8c6bd696636	Product name	1	20150902
c0200ab5-4954-454e-9676-30b741b245bd	Product name	1	20150730
76633df9-0d59-4b88-03ed-21dee1b966f8	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
76162-792-04	TOPCAREChildrens Cold and Cough and Runny Nose	120 mL in 1 BOTTLE	SUSPENSION	120		2
76162-792-04	TOPCAREChildrens Cold and Cough and Runny Nose	1 in 1 CARTON	SUSPENSION	1		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76162-792	TOPCARE CHILDRENS COLD AND COUGH AND RUNNY NOSE (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDE) SUSPENSION [TOPCO ASSOCIATES, LLC]	1	Current NDC, 2 package rows	20240901_8931d4ca-c599-49be-87e1-8c0598f38b77.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 146 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
night time cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Meijer, Inc.	d3bd0632-328c-4ad7-bb44-8383e1e51b8c	2024-10-28	Warnings	Exact identifier application number: M012
Premier Value	DEXTROMETHORPHAN HBR, GUAIFENESIN	PHARMACY VALUE ALLIANCE LLC	1ae3c6ac-1646-4c67-a9d5-9c383924b81a	2024-10-28	Warnings	Exact identifier application number: M012
nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	CVS Pharmacy	1c341cf5-ac33-4a6e-b023-a23d280d496c	2024-10-25	Warnings	Exact identifier application number: M012
Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Walgreen Company	b6d9f421-b236-4660-be7f-85a878f2fc61	2024-10-25	Warnings	Exact identifier application number: M012
COLD AND FLU MULTI-SYMPTOM RELIEF/COLD AND FLU NIGHTTIME RELIEF	ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE	Chain Drug Consortium, LLC	f9c3c12b-4efa-4ec4-a156-c403aff81753	2024-10-24	Warnings	Exact identifier application number: M012
NIGHTTIME COLD AND FLU RELIEF	ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE	Chain Drug Consortium, LLC	1deb60f3-e9be-4756-b0c1-527ef00dc741	2024-10-24	Warnings	Exact identifier application number: M012
Cold Medicine XL3 FORTE	ACETAMINOPHEN CHLORPHENIRAMINE MALEATE PHENYLEPHERINE HYDROCHLORIDE	Selder, S.A. de C.V.	51dd467b-aae8-41fa-e054-00144ff8d46c	2024-10-24	Warnings	Exact identifier application number: M012
Cold Flu and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	PUBLIX SUPER MARKETS INC	68a5930b-37db-439d-8fb9-7d7de07d8465	2024-10-24	Warnings	Exact identifier application number: M012
sinus pressure pain and cough	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	PUBLIX SUPER MARKETS INC	bb0225d5-6c32-2c64-e053-2995a90a829b	2024-10-24	Warnings	Exact identifier application number: M012
Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	PUBLIX SUPER MARKETS INC	01e1ad15-0ef5-4d6a-a9c1-19a5f2b20148	2024-10-24	Warnings	Exact identifier application number: M012
CareOne Fast Acting Nasal	PHENYLEPHRINE HYDROCHLORIDE	American Sales Company	95b22dce-ef54-4ab5-9cc3-0e1cefa09ec5	2024-10-24	Warnings	Exact identifier application number: M012
DAYTIME COLD AND FLU MULTI-SYMPTOM RELIEF	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Chain Drug Consortium, LLC	8cb0d0c8-c565-4c5a-97c5-8250a67e23a8	2024-10-24	Warnings	Exact identifier application number: M012
equate nighttime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Wal-Mart Stores Inc	0d07a534-c67f-4041-a07c-ed7f68dfc426	2024-10-23	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Marc Glassman, Inc.	90977b39-8ced-46bf-9d06-15306bce9b35	2024-10-23	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Marc Glassman, Inc.	5d29d3e3-3666-4a2f-835f-9e01bf8f5eeb	2024-10-23	Warnings	Exact identifier application number: M012
Sinus Severe	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	MARC GLASSMAN, INC.	e2325f33-e4e4-1269-e053-2995a90ab4ac	2024-10-23	Warnings	Exact identifier application number: M012
Sinus Pressure plus Pain PE	ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE	MARC GLASSMAN, INC.	a8240d98-f0b0-3ded-e053-2a95a90a5cf9	2024-10-23	Warnings	Exact identifier application number: M012
Sinus plus Headache	ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE	MARC GLASSMAN, INC.	a82401f5-65b1-11e9-e053-2a95a90a499e	2024-10-23	Warnings	Exact identifier application number: M012
Allergy Multi Symptom	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE	MARC GLASSMAN, INC.	a823db21-4863-45a6-e053-2995a90ab8e6	2024-10-23	Warnings	Exact identifier application number: M012
Cold Max	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	MARC GLASSMAN, INC.	e2346d0c-75cf-974c-e053-2a95a90a2857	2024-10-23	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
V1Q0O9OJ9Z	CHLORPHENIRAMINE MALEATE	113-92-8	CHLORPHENIRAMINE MALEATE
9D2RTI9KYH	DEXTROMETHORPHAN HYDROBROMIDE	6700-34-1	DEXTROMETHORPHAN HYDROBROMIDE
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1086750	acetaminophen 160 MG / chlorpheniramine maleate 1 MG / dextromethorphan HBr 5 MG in 5 mL Oral Suspension	PSN	8931d4ca-c599-49be-87e1-8c0598f38b77	2
1086750	acetaminophen 32 MG/ML / chlorpheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral Suspension	SCD	8931d4ca-c599-49be-87e1-8c0598f38b77	2
1086750	acetaminophen 160 MG / chlorpheniramine maleate 1 MG / dextromethorphan hydrobromide 5 MG per 5 ML Oral Suspension	SY	8931d4ca-c599-49be-87e1-8c0598f38b77	2
1086750	APAP 32 MG/ML / Chlorpheniramine Maleate 0.2 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML Oral Suspension	SY	8931d4ca-c599-49be-87e1-8c0598f38b77	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
76162-792-04	76162079204	1 BOTTLE in 1 CARTON (76162-792-04) / 120 mL in 1 BOTTLE	1 bottle	2024-08-12	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Topcare Children's Cold & Cough & Runny Nose Relief	Topco Associates, LLC	2025-11-11	HUMAN OTC DRUG LABEL	2