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 103 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
equate MAXIMUM STRENGTH DAYTIME SEVERE Cold and Flu SOFTGELS	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	WALMART INC.	3862aaa5-2281-e8f9-e063-6294a90a0f7e	2025-09-09	Warnings	Exact identifier application number: M012
McKesson Sugar Free Cough Suppressant Oral Anesthetic	MENTHOL LOZENGE	McKesson Medical-Surgical	e0dfa6ca-b311-25cb-e053-2a95a90a12cc	2025-09-09	Warnings	Exact identifier application number: M012
Medique at Home Decorel Forte	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Unifirst First Aid Corporation	e648f017-9e30-df6c-e053-2995a90adcd0	2025-09-09	Warnings	Exact identifier application number: M012
Medi-First Honey Lemon Cough Drops	MENTHOL 8.6 MG	Unifirst First Aid Corporation	826e1b87-e5a9-8637-e053-2991aa0aded1	2025-09-09	Warnings	Exact identifier application number: M012
Unishield Cherry Cough	MENTHOL	Unishield	b8297bc1-44b2-3de0-e053-2995a90ad01b	2025-09-09	Warnings	Exact identifier application number: M012
McKesson Cough Supressant	MENTHOL	McKesson Medical-Surgical	db5e0490-2ed8-2d53-e053-2a95a90a98f5	2025-09-09	Warnings	Exact identifier application number: M012
Duratuss AC	CODEINE PHOSPHATE, DEXBROMPHENIRAMINE MALEATE	Poly Pharmaceuticals, Inc.	3e5ed178-d5d9-b8d4-e063-6394a90a91db	2025-09-09	Warnings	Exact identifier application number: M012
Rompe Pecho CF	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Efficient Laboratories Inc	96c4dee1-6e66-4442-a7e3-56e874414c17	2025-09-09	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu Lil Drug Store Products	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE	Lil' Drug Store Products, Inc	57c458ed-7987-453b-ab24-bbfa6580f920	2025-09-09	Warnings	Exact identifier application number: M012
equate MAXIMUM STRENGTH NIGHTTIME SEVERE Cold and Flu SOFTGELS	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	WALMART INC.	38637189-d1ee-9405-e063-6394a90ae8b8	2025-09-09	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Walgreens	fd52d8d8-7cd1-4e92-86da-354a1d5213c2	2025-09-08	Warnings	Exact identifier application number: M012
Green Guard Advanced Sinus Relief	ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE	Unifirst First Aid Corporation	e8e5fb21-a7fd-44d1-b9c4-83e949699ca6	2025-09-08	Warnings	Exact identifier application number: M012
Medi-First Sinus Decongestant	PHENYLEPHRINE HYDROCHLORIDE	Unifirst First Aid Corporation	9654f5cd-74d7-44a2-9674-666d1e94ffa7	2025-09-08	Warnings	Exact identifier application number: M012
Otis Clapp Mygrex	ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE	Unifirst First Aid Corporation	f196f2c5-a100-42b1-bd01-0327b223838e	2025-09-08	Warnings	Exact identifier application number: M012
Medique Diphen	DIPHENHYDRAMINE HYDROCHLORIDE	Unifirst First Aid Corporation	b61ee2e0-2543-447d-9fc4-23363d46ce04	2025-09-08	Warnings	Exact identifier application number: M012
Green Guard Allergy 2 Relief	PHENYLEPHRINE HYDROCHLORIDE	Unifirst First Aid Corporation	16fddca9-a66b-41e6-9423-eaf091d3971e	2025-09-08	Warnings	Exact identifier application number: M012
Medique Medi-Phenyl	PHENYLEPHRINE HYDROCHLORIDE	Unifirst First Aid Corporation	d7d62ac1-1333-4366-884b-26537766ce38	2025-09-08	Warnings	Exact identifier application number: M012
Unishield Sinus Decongestant	PHENYLEPHRINE HCL	Unishield	b8f68d9d-2d38-414a-e053-2a95a90a15ec	2025-09-08	Warnings	Exact identifier application number: M012
McKesson Sinus Pain and Pressure Relief	ACETAMINOPHEN, PHENYLEPHRINE HCL	McKesson Medical-Surgical	e0cbb213-4f4f-4045-e053-2a95a90a2a18	2025-09-08	Warnings	Exact identifier application number: M012
Medique Medicidin D	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE	Unifirst First Aid Corporation	1f172d58-4050-424b-9743-130d8e618fe8	2025-09-08	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