topcare nite time cold and flu relief

Product NDC: 36800-459
11-digit product format: 368000459
Labeler code: 36800
Product ID: 36800-459_dd544442-703d-46c9-bc4f-d9e9c9e6cc32
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen, Dextromethorphan HBr, Doxylamine succinate
Dosage form: SOLUTION
Route: ORAL
Labeler: Topco Associates LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2011-08-19
Substance: ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active strength: 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL
Pharmacologic classes: Antihistamine [EPC], Histamine Receptor Antagonists [MoA], 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: 2027-12-31
Current FDA listing: Yes

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	36800-459	36800-459-30	D	Discontinued by firm		2026-10-21
excluded package	package	36800-459	36800-459-38	D	Discontinued by firm		2026-10-21

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 · 24 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	36800-459-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	36800-459-38	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	36800-459-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	36800-459-38	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	36800-459-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	36800-459-38	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	36800-459-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	36800-459-38	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	36800-459-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	36800-459-38	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	36800-459-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	36800-459-38	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	36800-459-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	36800-459-38	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	36800-459-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	36800-459-38	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	36800-459-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	36800-459-38	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	36800-459-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	36800-459-38	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	36800-459-30	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	36800-459-38	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	36800-459-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	36800-459-38	`557ba5c1ecfa…`	`9c80585c8c6e…`

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 nite time cold and flu relief
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	650 mg/30mL
DEXTROMETHORPHAN HYDROBROMIDE	30 mg/30mL
DOXYLAMINE SUCCINATE	12.5 mg/30mL

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
9D2RTI9KYH	Internal UNII lookup
V9BI9B5YI2	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1043400	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
f868e4a0-e9fb-4e6a-9984-29a218246241	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

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
36800-459-30	Topco Associates LLC. Nite Time Cold & Flu Relief Drug Facts
36800-459-34	Topco Associates LLC. Nite Time Cold & Flu Relief Drug Facts
36800-459-38	Topco Associates LLC. Nite Time Cold & Flu Relief Drug Facts
36800-459-40	Topco Associates LLC. Nite Time Cold & Flu Relief Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
36800-459-30	topcare nite time cold and flu relief	177 mL in 1 BOTTLE	SOLUTION	177		11
36800-459-34	topcare nite time cold and flu relief	237 mL in 1 BOTTLE	SOLUTION	237		11
36800-459-38	topcare nite time cold and flu relief	296 mL in 1 BOTTLE	SOLUTION	296		11
36800-459-40	topcare nite time cold and flu relief	355 mL in 1 BOTTLE	SOLUTION	355		11
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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	TOPCARE NITE TIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [TOPCO ASSOCIATES LLC]	4
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	TOPCARE NITE TIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [TOPCO ASSOCIATES LLC]	4
DOXYLAMINE SUCCINATE	ACTIVE INGREDIENT	V9BI9B5YI2	TOPCARE NITE TIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [TOPCO ASSOCIATES LLC]	4
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	TOPCARE NITE TIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [TOPCO ASSOCIATES LLC]	4
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	TOPCARE NITE TIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [TOPCO ASSOCIATES LLC]	4
DOXYLAMINE	ACTIVE MOIETY	95QB77JKPL	TOPCARE NITE TIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [TOPCO ASSOCIATES LLC]	4
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	TOPCARE NITE TIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [TOPCO ASSOCIATES LLC]	4
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	TOPCARE NITE TIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [TOPCO ASSOCIATES LLC]	4
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	TOPCARE NITE TIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [TOPCO ASSOCIATES LLC]	4
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	TOPCARE NITE TIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [TOPCO ASSOCIATES LLC]	4
HIGH FRUCTOSE CORN SYRUP	INACTIVE INGREDIENT	XY6UN3QB6S	TOPCARE NITE TIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [TOPCO ASSOCIATES LLC]	4
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	TOPCARE NITE TIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [TOPCO ASSOCIATES LLC]	4
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	TOPCARE NITE TIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [TOPCO ASSOCIATES LLC]	4
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	TOPCARE NITE TIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [TOPCO ASSOCIATES LLC]	4
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	TOPCARE NITE TIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [TOPCO ASSOCIATES LLC]	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	TOPCARE NITE TIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [TOPCO ASSOCIATES LLC]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
36800-459	TOPCARE NITE TIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [TOPCO ASSOCIATES LLC]	10	Current NDC, Legacy NDC, 4 package rows	20241027_f868e4a0-e9fb-4e6a-9984-29a218246241.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 113 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
topcare childrens cold cough	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE	Topco Associates LLC	40a6a7e3-6ec9-4005-9406-9d5b044b3c21	2025-06-16	Warnings	Exact identifier application number: M012
Daytime Nighttime Sinus Relief	ACETAMINOPHEN, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HCL	Target Corporation	23f50b88-52c3-2029-e063-6394a90ac73e	2025-06-14	Warnings	Exact identifier application number: M012
Cough Drops Dollar General Berries Flavor 25ct	PECTIN	Dollar General Corporation	c53c19a9-5984-4b08-ae46-a53dc8bb7d74	2025-06-13	Warnings	Exact identifier application number: M012
Cough Drops Dollar General Strawberry Flavor 25ct	PECTIN	Dollar General Corporation	d82034ca-b7fd-48c8-ab4a-8e1e56418324	2025-06-13	Warnings	Exact identifier application number: M012
Diphenhydramine HCL	DIPHENHYDRAMINE HCL	Belleview Biosciences	1db57d86-39f0-f8ca-e063-6394a90a6397	2025-06-12	Warnings	Exact identifier application number: M012
TARGET Cold and Cough and Nighttime Value Pack	BROMPHENIRAMINE MALEATE,DEXTROMETHORPHAN HBR,DIPHENHYDRAMINE HCL,	TARGET CORPORATION	ce536313-7265-405c-88b7-f45e62781da5	2025-06-11	Warnings	Exact identifier application number: M012
Capron Max	DEXTROMETHORPHAN HBR AND PYRILAMINE MALEATE	Capital Pharmaceutical, LLC	3756812b-f128-8946-e063-6294a90a59ba	2025-06-11	Warnings	Exact identifier application number: M012
SAFETUSSIN Non Drowsy Cough plus chest congestion	DEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESIN	KRAMER LABORATORIES	60311ca3-8544-417e-aa29-e9f65c6692ba	2025-06-11	Warnings	Exact identifier application number: M012
Cold Max Nighttime	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	RETAIL BUSINESS SERVICES , LLC.	e65d2815-6932-123c-e053-2a95a90a2cf9	2025-06-10	Warnings	Exact identifier application number: M012
Cold Head Congestion Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	American Sales Company	0cc66c6c-db26-4bb2-a97d-c4106210d70c	2025-06-10	Warnings	Exact identifier application number: M012
Nighttime Cough DM	DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	L.N.K. International, Inc.	75a9c736-bc7e-4b7f-84ea-9474a37508ec	2025-06-10	Warnings	Exact identifier application number: M012
DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN	DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN	KJD Pharma Private Limited	8877bb8d-479f-4968-8033-5c269d449a46	2025-06-10	Warnings	Exact identifier application number: M012
Benadryl	DIPHENHYDRAMINE HYDROCHLORIDE	Morning Star OTC	f4ff84b3-bb0c-4900-8ba4-6d1b90394782	2025-06-09	Warnings	Exact identifier application number: M012
Equate Kids Daytime Dex Cough Gels	DEXTROMETHORPHAN	Walmart	37269cd6-1528-9879-e063-6394a90a2b54	2025-06-09	Warnings	Exact identifier application number: M012
Nuvicare DayTime Cold and Flu Softgel	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	NUVICARE LLC	bdc35570-c8df-4797-a13e-7f2479ec42b7	2025-06-09	Warnings	Exact identifier application number: M012
Nuvicare DayTime and NightTime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE	NUVICARE LLC	f5764925-c586-40e4-8252-24d92389af01	2025-06-09	Warnings	Exact identifier application number: M012
Nuvicare NightTime Cold and Flu Softgel	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	NUVICARE LLC	2a29f0ed-d86b-4787-84e0-f7a8c5e7581f	2025-06-09	Warnings	Exact identifier application number: M012
Nuvicare DayTime and NightTime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE	NUVICARE LLC	7fa8e4ad-95cb-4905-90db-d53b3bc87c41	2025-06-09	Warnings	Exact identifier application number: M012
Vaporizing Steam Liquid	MEDICATED COUGH SUPPRESSANT	NeilMed Pharmaceuticals Inc.	36cf6218-adb8-9d8b-e063-6394a90a49a0	2025-06-05	Warnings	Exact identifier application number: M012
Geri-Tussin DM	DEXTROMETHORPHAN HBR, GUAIFENESIN	Geri-Care Pharmaceuticals, Corp	7e2fb43c-a7f1-4c1d-a700-7c6510999c03	2025-06-05	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN
9D2RTI9KYH	DEXTROMETHORPHAN HYDROBROMIDE	6700-34-1	DEXTROMETHORPHAN HYDROBROMIDE
V9BI9B5YI2	DOXYLAMINE SUCCINATE	562-10-7	DOXYLAMINE SUCCINATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1043400	acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral Solution	PSN	f868e4a0-e9fb-4e6a-9984-29a218246241	11
1043400	acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution	SCD	f868e4a0-e9fb-4e6a-9984-29a218246241	11
1043400	acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral Solution	SY	f868e4a0-e9fb-4e6a-9984-29a218246241	11
1043400	acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral Solution	SY	f868e4a0-e9fb-4e6a-9984-29a218246241	11
1043400	APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution	SY	f868e4a0-e9fb-4e6a-9984-29a218246241	11
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
36800-459-30	36800045930	177 mL in 1 BOTTLE	177 ml					Historical
36800-459-34	36800045934	237 mL in 1 BOTTLE (36800-459-34)	237 ml	2012-07-11	0000-00-00	No	No	Current
36800-459-38	36800045938	296 mL in 1 BOTTLE	296 ml					Historical
36800-459-40	36800045940	355 mL in 1 BOTTLE (36800-459-40)	355 ml	2012-07-10	0000-00-00	No	No	Current

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
Topco Associates LLC. Nite Time Cold & Flu Relief Drug Facts	Topco Associates LLC	2026-05-13	HUMAN OTC DRUG LABEL	11