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 19 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Aspirin Regular Strength	ASPIRIN	Rite Aid Corporation	879e2258-f61b-47ad-a4b1-7d1e78823570	2026-03-05	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	ARMY AND AIR FORCE EXCHANGE SERVICE	87c580d3-6009-4be9-aea7-13539fbe6e31	2026-03-05	Warnings	Exact identifier application number: M013
Aspirin Low Dose Chewable Orange	ASPIRIN	MAJOR PHARMACEUTICALS	fb3a8e38-e991-49c9-93dc-1d29c0a97ba3	2026-03-05	Warnings	Exact identifier application number: M013
Infants Pain and Fever	ACETAMINOPHEN	Kroger	41e149df-4140-95cc-e063-6294a90a866b	2026-03-03	Warnings	Exact identifier application number: M013
Medique Pain Off	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Sportpharm LLC	2b35acdc-ff88-46e6-a108-5240aac1d53f	2026-03-03	Warnings	Exact identifier application number: M013
Childrens Pain and Fever	ACETAMINOPHEN	Best Choice (Valu Merchandisers Company)	a8a0d9a5-1a36-4ed2-ae9c-7e1a3d674c07	2026-03-03	Warnings	Exact identifier application number: M013
pain relief	ACETAMINOPHEN	HyVee Inc	6820a515-4004-407b-969b-c4069dc0c3b5	2026-02-26	Warnings	Exact identifier application number: M013
Acetaminophen, Diphenhydramine Hydrochloride	ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE	LEADER/ Cardinal Health 110, Inc.	7be4d67e-1af9-f059-e053-2991aa0a382e	2026-02-26	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	NCS HealthCare of KY, LLC dba Vangard Labs	f32fc2e9-c0e3-4a25-8399-9cdba6ae8a16	2026-02-26	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	NCS HealthCare of KY, LLC dba Vangard Labs	1f4ac0e6-e986-4c22-8248-0691d64e1a30	2026-02-26	Warnings	Exact identifier application number: M013
Childrens Chewable Acetaminophen	ACETAMINOPHEN	Discount Drug Mart	f413a617-1166-4940-b6ec-fae32238a780	2026-02-26	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	NCS HealthCare of KY, LLC dba Vangard Labs	19735691-33f3-4e19-85ad-e5f270251ec5	2026-02-26	Warnings	Exact identifier application number: M013
Acetaminophen Liquid / Acetaminophen Diphenhydramine HCl Liquid	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	Kroger	44520aa1-b63f-4239-e063-6394a90a5e14	2026-02-25	Warnings	Exact identifier application number: M013
Leader Extra Strength Effervescent Antacid and Pain Reliever	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Cardinal Health	c5d7bf5f-3e59-52f2-e053-2a95a90a4a00	2026-02-25	Warnings	Exact identifier application number: M013
Childrens Pain and Fever	ACETAMINOPHEN	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	12fd643d-7c60-453f-a81f-407ed20e8725	2026-02-25	Warnings	Exact identifier application number: M013
Childrens Pain and Fever	ACETAMINOPHEN	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	d96a1531-772b-4a5c-89e4-66fff1fa3d78	2026-02-25	Warnings	Exact identifier application number: M013
Gentle Care Kit	ZINC OXIDE	Kenvue Brands LLC	4b8f7a5a-2fc4-ea00-e063-6294a90ab95b	2026-02-24	Warnings	Exact identifier application number: M013
Excedrin PM Triple Action Caplets and Excedrin Extra Strength Pain Reliever	ACETAMINOPHEN, ASPIRIN (NSAID), CAFFEINE, AND DIPHENHYDRAMINE CITRATE	Haleon US Holdings LLC	444fa225-c204-45d1-b3b3-aa5650ee5d07	2026-02-23	Warnings	Exact identifier application number: M013
Excedrin Extra Strength and Excedrin Tension Headache	ACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINE	Haleon US Holdings LLC	2c8df1c7-7864-48df-939c-d9ae22e0f52c	2026-02-23	Warnings	Exact identifier application number: M013
Equate Childrens Pain and Fever	ACETAMINOPHEN	Wal-Mart Stores Inc	40eedfe9-54e1-40a2-b4a2-55ff708b89cd	2026-02-23	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