Topcare childrens cold and cough

Product NDC: 36800-987
Requested package NDC: 36800-987-26
11-digit product format: 368000987
Labeler code: 36800
Product ID: 36800-987_ca8508df-fcbd-4b8c-82f8-bbfb5c9f5c05
Type: HUMAN OTC DRUG
Nonproprietary name: Brompheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl
Dosage form: SOLUTION
Route: ORAL
Labeler: Topco Associates LLC
Application: part341
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2006-09-29
Marketing end: 0000-00-00
Substance: BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength: 2 mg/10mL; mg/10mL; mg/10mL
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	36800-987	36800-987-26	D	Discontinued by firm		2026-10-05

Adverse event summaries are temporarily unavailable. Other product information remains available.

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
36800-987-26	Topcare childrens cold and cough	118 mL in 1 BOTTLE	SOLUTION	118		4
36800-987-26	Topcare childrens cold and cough	1 in 1 CARTON	SOLUTION	1		4

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
36800-987-26	ML - Milliliter	36800-987	522b69e1-cb58-4954-b119-7b1fa83e86df	1	2012-07-24

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BROMPHENIRAMINE MALEATE	ACTIVE INGREDIENT	IXA7C9ZN03	TOPCARE CHILDRENS COLD AND COUGH ELIXIR (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [TOPCO ASSOCIATES LLC]	1
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	TOPCARE CHILDRENS COLD AND COUGH ELIXIR (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [TOPCO ASSOCIATES LLC]	1
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	TOPCARE CHILDRENS COLD AND COUGH ELIXIR (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [TOPCO ASSOCIATES LLC]	1
BROMPHENIRAMINE	ACTIVE MOIETY	H57G17P2FN	TOPCARE CHILDRENS COLD AND COUGH ELIXIR (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [TOPCO ASSOCIATES LLC]	1
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	TOPCARE CHILDRENS COLD AND COUGH ELIXIR (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [TOPCO ASSOCIATES LLC]	1
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	TOPCARE CHILDRENS COLD AND COUGH ELIXIR (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [TOPCO ASSOCIATES LLC]	1

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
36800-987	TOPCARE CHILDRENS COLD AND COUGH (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [TOPCO ASSOCIATES LLC]	4	Legacy NDC, 2 package rows	20241119_d141bcb7-b509-4011-b17a-7d67635ec1e7.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
IXA7C9ZN03	BROMPHENIRAMINE MALEATE	980-71-2	BROMPHENIRAMINE MALEATE
9D2RTI9KYH	DEXTROMETHORPHAN HYDROBROMIDE	6700-34-1	DEXTROMETHORPHAN HYDROBROMIDE
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1090463	brompheniramine maleate 1 MG / dextromethorphan HBr 5 MG / phenylephrine HCl 2.5 MG in 5 mL Oral Solution	PSN	d141bcb7-b509-4011-b17a-7d67635ec1e7	4
1090463	brompheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 1 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution	SCD	d141bcb7-b509-4011-b17a-7d67635ec1e7	4
1090463	brompheniramine maleate 1 MG / dextromethorphan hydrobromide 5 MG / phenylephrine hydrochloride 2.5 MG per 5 ML Oral Solution	SY	d141bcb7-b509-4011-b17a-7d67635ec1e7	4
1090463	brompheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral Solution	SY	d141bcb7-b509-4011-b17a-7d67635ec1e7	4

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
36800-987-26	36800098726	1 BOTTLE in 1 CARTON (36800-987-26) > 118 mL in 1 BOTTLE	1 bottle	2006-09-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Topco Associates LLC. Children’s Cold and Cough Drug Facts	Topco Associates LLC	2024-11-17	HUMAN OTC DRUG LABEL	4