TopCare Day Time Nite Time Cold and Flu Relief

Product NDC: 36800-301
11-digit product format: 368000301
Labeler code: 36800
Product ID: 36800-301_4ec4eb9a-e323-4e7d-9fc4-8607cac3cb94
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl
Dosage form: KIT
Labeler: Topco Associates LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2018-09-08
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 16 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	36800-301-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	36800-301-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	36800-301-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	36800-301-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	36800-301-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	36800-301-02	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	36800-301-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	36800-301-02	`0efc9e666f02…`	`f202fb6c5f17…`

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 Day Time Nite Time Cold and Flu Relief
Listing expiration: 2027-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1042675	Internal RxNorm lookup
1043400	Internal RxNorm lookup
1113705	Internal RxNorm lookup
2604561	Internal RxNorm lookup
2687211	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
c00ff684-acaf-4fbe-bc74-7e48751b927d	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
59361619-24d9-b610-eca6-5a7f25ed5e03	Product name	5	20240909
f489e8f3-5c9e-4818-b539-a73587edcfc7	Product name	2	20240229
0f7ae452-206d-4fc4-868d-56fc47074084	Product name	1	20231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3df	Product name	2	20190930
f4368033-af8c-41bf-a84b-ff77392b8522	Product name	1	20161229
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814	Product name	3	20150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485	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
36800-301-02	TopCare Day Time Nite Time Cold and Flu Relief	1 in 1 CARTON	KIT	1		5
36800-459-40	TopCare Day Time Nite Time Cold and Flu Relief	355 mL in 1 BOTTLE	SOLUTION	355 mL	650 mg in 30mL	5
36800-522-40	TopCare Day Time Nite Time Cold and Flu Relief	355 mL in 1 BOTTLE	SOLUTION	355 mL	5 mg in 15mL	5

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 131 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tussin Multi Symptom Cold CF	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE	Best Choice (Valu Merchandisers Company)	539b8972-2a46-468e-ad27-6672d746feb7	2024-12-10	Warnings	Exact identifier application number: M012
DUAL ACTION GLACIER MINT COUGH SUPPRESSANT ORAL ANESTHETIC	MENTHOL	Ricola USA Inc.	db2ab9be-507d-4768-9d00-188f751b7726	2024-12-10	Warnings	Exact identifier application number: M012
Adult Allergy Relief	CALMCO ALLERGY RELIEF	CalmCo	08288825-0f38-b6a3-e063-6394a90aa358	2024-12-07	Warnings	Exact identifier application number: M012
Original Herb Cough Drops	MENTHOL	Ricola Ag	c142663f-086e-4ab7-a758-9107d7077537	2024-12-05	Warnings	Exact identifier application number: M012
DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETIC	MENTHOL	Ricola Ag	984c9793-163c-4b97-b244-9b471966a122	2024-12-05	Warnings	Exact identifier application number: M012
BENZEDREX	PROPYLHEXEDRINE	BF ASCHER AND CO INC	00d8c237-3eee-1d9f-e063-6394a90aeb86	2024-12-05	Warnings	Exact identifier application number: M012
Cold Multi Symptom Daytime Nighttime	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Chain Drug Marketing Association	d5cbb5b0-564c-429e-b680-fa683e796393	2024-12-05	Warnings	Exact identifier application number: M012
Cold Relief Multi-Symptom	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	TopCare	de8a623f-7b10-4d56-a74b-3737e7716ffe	2024-12-05	Warnings	Exact identifier application number: M012
Cold Max Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	TopCo Associates LLC	9773958b-c5e5-4da7-a8e9-6b6c223a2b30	2024-12-05	Warnings	Exact identifier application number: M012
Cold Plus Head Congestion Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	TopCo Associates LLC	399e0e51-c2a7-451c-b74d-d3db140cef69	2024-12-05	Warnings	Exact identifier application number: M012
Head Congestion Plus Mucus PE	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	United Natural Foods, Inc. dba UNFI	09531edc-8dbd-451f-ae02-f922e9e8c248	2024-12-05	Warnings	Exact identifier application number: M012
DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETIC	MENTHOL	Ricola Ag	71ca8af7-172d-40da-be1e-ff3ab5568e74	2024-12-05	Warnings	Exact identifier application number: M012
SUGAR FREE ORIGINAL SWISS HERB COUGH SUPPRESSANT THROAT DROPS	MENTHOL	Ricola Ag	b790a91c-33be-4bc3-bdeb-eae6f366f085	2024-12-05	Warnings	Exact identifier application number: M012
EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT COUGH SUPPRESSANT	MENTHOL	Ricola Ag	ea42e516-2ef8-41c9-ae4e-571f0147bc6b	2024-12-05	Warnings	Exact identifier application number: M012
RICOLA MAX THROAT CARE SWISS CHERRY	MENTHOL	Ricola Ag	8b2d5c0f-509e-447d-b071-d73c4785f120	2024-12-05	Warnings	Exact identifier application number: M012
SUGAR FREE GREEN TEA WITH ECHINACEA COUGH SUPPRESSANT THROAT DROPS	MENTHOL	Ricola Ag	8ae0e21a-44a0-4a2c-9880-54eeeaea07ea	2024-12-05	Warnings	Exact identifier application number: M012
MOUNTAIN HERB SUGAR FREE WITH STEVIA COUGH SUPPRESSANT ORAL ANESTHETIC	MENTHOL	Ricola Ag	6d82469b-d51c-4824-9830-6c1874ad4fe4	2024-12-05	Warnings	Exact identifier application number: M012
RICOLA MAX THROAT CARE COOL PEPPERMINT	MENTHOL	Ricola Ag	e8bedf6f-4a2e-4a76-ba8c-bdb249fb6ce5	2024-12-05	Warnings	Exact identifier application number: M012
DUAL ACTION HONEY LEMON COUGH SUPPRESSANT ORAL ANESTHETIC	MENTHOL	Ricola Ag	a535717d-ba55-45e9-9fc3-711b5d7dbf57	2024-12-05	Warnings	Exact identifier application number: M012
THE ORIGINAL NATURAL HERB COUGH DROPS	MENTHOL	Ricola Ag	4330ee8d-0b37-4a93-886b-5fc6e6598da7	2024-12-05	Warnings	Exact identifier application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2687211	{1 (acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution) / 1 (acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML Oral Solution) } Pack	GPCK	c00ff684-acaf-4fbe-bc74-7e48751b927d	5
2687211	1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG in 15 mL Oral Solution) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG in 15 mL Oral Solution) Pack	PSN	c00ff684-acaf-4fbe-bc74-7e48751b927d	5
1042675	acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG in 15 mL Oral Solution	PSN	c00ff684-acaf-4fbe-bc74-7e48751b927d	5
1113705	acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution	PSN	c00ff684-acaf-4fbe-bc74-7e48751b927d	5
2604561	acetaminophen 650 MG / dextromethorphan HBr 20 MG in 30 mL Oral Solution	PSN	c00ff684-acaf-4fbe-bc74-7e48751b927d	5
1043400	acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral Solution	PSN	c00ff684-acaf-4fbe-bc74-7e48751b927d	5
1042675	acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution	SCD	c00ff684-acaf-4fbe-bc74-7e48751b927d	5
1113705	acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution	SCD	c00ff684-acaf-4fbe-bc74-7e48751b927d	5
2604561	acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML Oral Solution	SCD	c00ff684-acaf-4fbe-bc74-7e48751b927d	5
1043400	acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution	SCD	c00ff684-acaf-4fbe-bc74-7e48751b927d	5
2687211	1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG per 15 mL Oral Solution) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG per 15 mL Oral Solution) Pack	SY	c00ff684-acaf-4fbe-bc74-7e48751b927d	5
1042675	acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG per 15 ML Oral Solution	SY	c00ff684-acaf-4fbe-bc74-7e48751b927d	5
1113705	acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution	SY	c00ff684-acaf-4fbe-bc74-7e48751b927d	5
2604561	acetaminophen 325 MG / dextromethorphan HBr 10 MG per 15 ML Oral Solution	SY	c00ff684-acaf-4fbe-bc74-7e48751b927d	5
1043400	acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral Solution	SY	c00ff684-acaf-4fbe-bc74-7e48751b927d	5
1042675	acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG per 30 ML Oral Solution	SY	c00ff684-acaf-4fbe-bc74-7e48751b927d	5
1113705	acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution	SY	c00ff684-acaf-4fbe-bc74-7e48751b927d	5
2604561	acetaminophen 650 MG / dextromethorphan HBr 20 MG per 30 ML Oral Solution	SY	c00ff684-acaf-4fbe-bc74-7e48751b927d	5
1043400	acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral Solution	SY	c00ff684-acaf-4fbe-bc74-7e48751b927d	5
1042675	APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution	SY	c00ff684-acaf-4fbe-bc74-7e48751b927d	5
1113705	APAP 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution	SY	c00ff684-acaf-4fbe-bc74-7e48751b927d	5
2604561	APAP 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML Oral Solution	SY	c00ff684-acaf-4fbe-bc74-7e48751b927d	5
1043400	APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution	SY	c00ff684-acaf-4fbe-bc74-7e48751b927d	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
36800-301-02	36800030102	1 KIT in 1 CARTON (36800-301-02) * 355 mL in 1 BOTTLE (36800-459-40) * 355 mL in 1 BOTTLE (36800-522-40)	1 kit	2018-09-08	0000-00-00	No	No	Current
36800-459-40	36800045940	355 mL in 1 BOTTLE	355 ml					Historical
36800-522-40	36800052240	355 mL in 1 BOTTLE	355 ml					Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Topco Associates LLC. DayTime/NiteTime Cold & Flu Relief Drug Facts	Topco Associates LLC	2026-05-26	HUMAN OTC DRUG LABEL	6