Topcare pain and fever

Product NDC: 36800-161
11-digit product format: 368000161
Labeler code: 36800
Product ID: 36800-161_379dcaf6-995b-4e66-b09b-d0ddf0d4e571
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen
Dosage form: SUSPENSION
Route: ORAL
Labeler: Topco Associates LLC
Application: M013
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2011-08-26
Substance: ACETAMINOPHEN
Active strength: 160 mg/5mL
NDC exclude flag: No
Listing certified through: 2026-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	36800-161	36800-161-16	D	Discontinued by firm		2026-10-15

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`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 pain and fever
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	160 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
307668	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
950b16d5-65db-402d-8ec6-eec9e1e174dd	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
36800-161-10	Topcare pain and fever	1 in 1 CARTON	SUSPENSION	1	8
36800-161-10	Topcare pain and fever	30 mL in 1 BOTTLE	SUSPENSION	30	8
36800-161-16	Topcare pain and fever	1 in 1 CARTON	SUSPENSION	1	8
36800-161-16	Topcare pain and fever	59 mL in 1 BOTTLE	SUSPENSION	59	8

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	TOPCARE PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [TOPCO ASSOCIATES LLC]	4
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	TOPCARE PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [TOPCO ASSOCIATES LLC]	4
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	TOPCARE PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [TOPCO ASSOCIATES LLC]	4
BUTYLPARABEN	INACTIVE INGREDIENT	3QPI1U3FV8	TOPCARE PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [TOPCO ASSOCIATES LLC]	4
CALCIUM SULFATE	INACTIVE INGREDIENT	WAT0DDB505	TOPCARE PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [TOPCO ASSOCIATES LLC]	4
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	TOPCARE PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [TOPCO ASSOCIATES LLC]	4
CARRAGEENAN	INACTIVE INGREDIENT	5C69YCD2YJ	TOPCARE PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [TOPCO ASSOCIATES LLC]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TOPCARE PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [TOPCO ASSOCIATES LLC]	4
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	TOPCARE PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [TOPCO ASSOCIATES LLC]	4
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	TOPCARE PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [TOPCO ASSOCIATES LLC]	4
HIGH FRUCTOSE CORN SYRUP	INACTIVE INGREDIENT	XY6UN3QB6S	TOPCARE PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [TOPCO ASSOCIATES LLC]	4
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	TOPCARE PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [TOPCO ASSOCIATES LLC]	4
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	TOPCARE PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [TOPCO ASSOCIATES LLC]	4
SODIUM PHOSPHATE, TRIBASIC	INACTIVE INGREDIENT	A752Q30A6X	TOPCARE PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [TOPCO ASSOCIATES LLC]	4
SORBITOL	INACTIVE INGREDIENT	506T60A25R	TOPCARE PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [TOPCO ASSOCIATES LLC]	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	TOPCARE PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [TOPCO ASSOCIATES LLC]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
36800-161	TOPCARE PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [TOPCO ASSOCIATES LLC]	8	Current NDC, Legacy NDC, 4 package rows	20240716_950b16d5-65db-402d-8ec6-eec9e1e174dd.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 20 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Excedrin Rapid Relief	ACETAMINOPHEN	Haleon US Holdings LLC	3a36b7ca-396e-cfd8-e063-6294a90a76ab	2026-02-22	Warnings	Exact identifier application number: M013
CHILDRENS Acetaminophen	CHILDRENS ACETAMINOPHEN	Kesin Pharma Corporation	4af5b025-1fd7-e825-e063-6294a90aa005	2026-02-16	Warnings	Exact identifier application number: M013
Infants TYLENOL	ACETAMINOPHEN	Kenvue Brands LLC	4a121a53-dbae-05c7-e063-6294a90aed89	2026-02-13	Warnings	Exact identifier application number: M013
MAX relief junior Grape	CHILDRENS ACETAMINOPHEN	ATLANTIC BIOLOGICALS CORP.	562d7901-44d6-4d9b-be8b-a8d468a22c43	2026-02-13	Warnings	Exact identifier application number: M013
acetaminophen	ACETAMINOPHEN	Major Pharmaceuticals	020fa486-31f0-4e0c-84d3-5b3aaded1eeb	2026-02-13	Warnings	Exact identifier application number: M013
ASPIRIN Low Strength	ASPIRIN	CVS Pharmacy	6e1c1129-562b-4a8a-ac37-db3cb2a82735	2026-02-11	Warnings	Exact identifier application number: M013
CVS Acetaminophen	ACETAMINOPHEN	CVS Pharmacy	3dd21aaf-13b2-9e81-e063-6294a90afaec	2026-02-11	Warnings	Exact identifier application number: M013
Pain Relief PM	ACETAMINOPHEN, ASPIRIN, DIPHENHYDRAMINE CITRATE	CVS Pharmacy	ddd78b28-6e10-4708-bed1-8aea087b3d82	2026-02-11	Warnings	Exact identifier application number: M013
Pain Relief	ACETAMINOPHEN	Topco Associates, LLC	2e31fe65-5f50-455b-99fa-c72879f43545	2026-02-10	Warnings	Exact identifier application number: M013
Pain Relief Childrens	ACETAMINOPHEN	Amerisource Bergen	9ea8bb1f-1924-4430-98bd-f2674d0da748	2026-02-09	Warnings	Exact identifier application number: M013
Acetaminophen , Caffeine and pyrilamine maleate	ACETAMINOPHEN , CAFFEINE AND PYRILAMINE MALEATE	Softgel Healthcare Pvt Ltd	4a61313e-1b48-29df-e063-6394a90a27f0	2026-02-09	Warnings	Exact identifier application number: M013
good sense aspirin	ASPIRIN	L. Perrigo Company	e9fddbc1-11fe-4cf6-8794-1650fa1b32ae	2026-02-07	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	Chain Drug Marketing Association, Inc.	2d375ec9-a528-4048-a15b-652fa20e74a7	2026-02-06	Warnings	Exact identifier application number: M013
Adult Low Dose Enteric Coated Aspirin	ASPIRIN	Sportpharm LLC	d3379569-7949-4f78-b634-5d4178b21ea4	2026-02-06	Warnings	Exact identifier application number: M013
Buffered Aspirin	ASPIRIN	Cardinal Health 110, LLC. DBA Leader	e5f68c1a-21f3-45a1-861f-229a95b3721c	2026-02-06	Warnings	Exact identifier application number: M013
pain relief extra strength	ACETAMINOPHEN	HyVee Inc	1e707628-08b1-4c72-b71c-2b4ae96071f2	2026-02-06	Warnings	Exact identifier application number: M013
CareOne Acetaminophen PM	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	American Sales Company	2d2ded37-f241-4976-886d-5c038a85bfe1	2026-02-05	Warnings	Exact identifier application number: M013
Dolex Fem	ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE	Pharmadel LLC	b1cab10b-19f1-f5d5-e053-2995a90a4d5f	2026-02-05	Warnings	Exact identifier application number: M013
Alka-Seltzer Extra Strength Pain Relief	ANHYDROUS CITRIC ACID, ASPIRIN	Bayer HealthCare LLC.	4a16b6e5-f0c6-e3a4-e063-6294a90a85ad	2026-02-05	Warnings	Exact identifier application number: M013
Pain Relief childrens	ACETAMINOPHEN	CVS PHARMACY	b8ab85a6-3eab-4ef4-a13d-5ac300480f63	2026-02-03	Warnings	Exact identifier application number: M013

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
307668	acetaminophen 160 MG in 5 mL Oral Suspension	PSN	950b16d5-65db-402d-8ec6-eec9e1e174dd	8
307668	acetaminophen 32 MG/ML Oral Suspension	SCD	950b16d5-65db-402d-8ec6-eec9e1e174dd	8
307668	acetaminophen 160 MG per 5 ML Oral Suspension	SY	950b16d5-65db-402d-8ec6-eec9e1e174dd	8
307668	acetaminophen 320 MG per 10 ML Oral Suspension	SY	950b16d5-65db-402d-8ec6-eec9e1e174dd	8
307668	acetaminophen 650 MG per 20.3 ML Oral Suspension	SY	950b16d5-65db-402d-8ec6-eec9e1e174dd	8
307668	acetaminophen 80 MG per 2.5 ML Oral Suspension	SY	950b16d5-65db-402d-8ec6-eec9e1e174dd	8
307668	APAP 32 MG/ML Oral Suspension	SY	950b16d5-65db-402d-8ec6-eec9e1e174dd	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
36800-161-10	36800016110	1 BOTTLE in 1 CARTON (36800-161-10) / 30 mL in 1 BOTTLE	1 bottle	2011-08-26	0000-00-00	No	No	Current
36800-161-16	36800016116	1 BOTTLE in 1 CARTON (36800-161-16) > 59 mL in 1 BOTTLE	1 bottle	2012-04-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Topco Associates LLC. Infant’s Pain & Fever Drug Facts	Topco Associates LLC	2024-07-03	HUMAN OTC DRUG LABEL	8