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 42 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Childrens Acetaminophen	ACETAMINOPHEN	Bryant Ranch Prepack	190bb2dc-92b4-4b59-a47f-a0251df8261c	2025-07-29	Warnings	Exact identifier application number: M013
Extra Strength NiteTime Pain Relief	ACETAMINOPHEN 500 MG,DIPHENHYDRAMINE HYDROCHLORIDE 25 MG TABLET	WALGREENS	c25c75c7-157f-1c0d-e053-2995a90a2e3c	2025-07-25	Warnings	Exact identifier application number: M013
Pain Reliever PM	ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE	Walmart Inc.	21ab3d58-bb0e-3e51-e063-6294a90ad415	2025-07-25	Warnings	Exact identifier application number: M013
Childrens TYLENOL	ACETAMINOPHEN	Kenvue Brands LLC	3a935584-6045-0a58-e063-6394a90a40c4	2025-07-23	Warnings	Exact identifier application number: M013
DR. SANA PAIN AND FEVER FOR Children	ACETAMINOPHEN	GADAL Laboratories, Inc	8a22a5ba-8623-4cca-8723-52b495403461	2025-07-23	Warnings	Exact identifier application number: M013
Duralgina	ACETAMINOPHEN	Menper Distributors Inc.	bb31f66c-80a9-4bdb-983b-cef5d21de5ff	2025-07-22	Warnings	Exact identifier application number: M013
Gesteira	ACETAMINOPHEN	Menper Distributors, Inc.	5a907289-564c-491b-98d5-d7f43eaaa1b2	2025-07-22	Warnings	Exact identifier application number: M013
Extra strength Acetaminophen PM	ACETAMINOPHEN 500MG/ DIPHENHYDRAMINE HCL 25MG	TIME CAP LABS INC	010c5c98-fc67-a9c3-e063-6394a90aa640	2025-07-21	Warnings	Exact identifier application number: M013
childrens pain and fever	ACETAMINOPHEN	Meijer Distribution Inc	44d50d79-6e47-429f-8cbe-6fcac4667732	2025-07-18	Warnings	Exact identifier application number: M013
ADWE Childrens Pain Fever	ACETAMINOPHEN	RARITAN PHARMACEUTICALS INC	79a3232f-0211-4c8a-acee-4f87e06ffc26	2025-07-17	Warnings	Exact identifier application number: M013
Pain Reliever	ACETAMINOPHEN	Walmart Inc.	24d191ca-a0c4-e1a8-e063-6394a90a7a2a	2025-07-16	Warnings	Exact identifier application number: M013
EXTRA STRENGTH HEADACHE RELIEF	ACETAMINOPHEN ASPIRIN CAFFEINE	WAL-MART STORES INC	d97073cd-b5d7-8c09-e053-2a95a90a8938	2025-07-16	Warnings	Exact identifier application number: M013
Pain Relief	ACETAMINOPHEN	BETTER LIVING BRANDS LLC.	f3005d0c-424e-0ab3-e053-2995a90a1c10	2025-07-16	Warnings	Exact identifier application number: M013
Pain Relief	ACETAMINOPHEN	Demoulas Super Markets, Inc	397fa6e1-37b2-8f51-e063-6394a90a7b94	2025-07-16	Warnings	Exact identifier application number: M013
Pain Relief	ACETAMINOPHEN	Demoulas Super Markets, Inc	39800c27-f39f-cd60-e063-6394a90acd55	2025-07-16	Warnings	Exact identifier application number: M013
Pain Relief	ACETAMINOPHEN	Demoulas Super Markets, Inc	397f2b63-733e-5b44-e063-6394a90a9718	2025-07-16	Warnings	Exact identifier application number: M013
EXTRA STRENGTH PAIN RELIEF	ACETAMINOPHEN, ASPIRIN, CAFFEINE	BETTER LIVING BRANDS, LLC	eb6026d5-d88a-f6b3-e053-2a95a90a5b20	2025-07-15	Warnings	Exact identifier application number: M013
Pain Relief PM	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE	Safeway	f9597abc-3f01-4b94-8078-228e0b74677e	2025-07-15	Warnings	Exact identifier application number: M013
Berkley and Jensen Pain Relief	ACETAMINOPHEN	BJWC	d3ee3341-93b8-487c-921e-2892d213efbb	2025-07-15	Warnings	Exact identifier application number: M013
Headache Relief Extra Strength	ACETAMINOPHEN, ASPIRIN, CAFFEINE	CVS Pharmacy	9e459853-5951-4ae7-88a6-85b502e9dd41	2025-07-14	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