topcare childrens pain and fever

Product NDC: 36800-202
11-digit product format: 368000202
Labeler code: 36800
Product ID: 36800-202_f5d35fd8-953d-48b6-a7a2-a79a9c3408db
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: 1990-01-15
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	36800-202	36800-202-28	D	Discontinued by firm		2026-09-09
excluded package	package	36800-202	36800-202-34	D	Discontinued by firm		2026-09-09

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	36800-202-34	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	36800-202-28	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	36800-202-34	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	36800-202-28	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	36800-202-34	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	36800-202-28	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	36800-202-34	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	36800-202-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	36800-202-34	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	36800-202-28	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	36800-202-34	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	36800-202-28	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	36800-202-34	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	36800-202-28	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	36800-202-34	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	36800-202-28	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	36800-202-34	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	36800-202-28	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	36800-202-34	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	36800-202-28	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	36800-202-34	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	36800-202-28	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	36800-202-34	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	36800-202-28	`557ba5c1ecfa…`	`9c80585c8c6e…`

Additional Listing Data#

Finished product: Yes
Brand name base: topcare childrens 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
911492d5-e065-4b8f-b2dc-cb6a6678d0ae	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
36800-202-00	topcare childrens pain and fever	236 mL in 1 BOTTLE	SUSPENSION	236	11
36800-202-00	topcare childrens pain and fever	1 in 1 CARTON	SUSPENSION	1	11
36800-202-26	topcare childrens pain and fever	1 in 1 CARTON	SUSPENSION	1	11
36800-202-26	topcare childrens pain and fever	118 mL in 1 BOTTLE	SUSPENSION	118	11
36800-202-28	topcare childrens pain and fever	148 mL in 1 BOTTLE	SUSPENSION	148	11
36800-202-28	topcare childrens pain and fever	1 in 1 CARTON	SUSPENSION	1	11
36800-202-34	topcare childrens pain and fever	118 mL in 1 BOTTLE	SUSPENSION	118	11
36800-202-34	topcare childrens pain and fever	2 in 1 CARTON	SUSPENSION	2	11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
36800-202-26	ML - Milliliter	36800-202	12f916a1-ae01-4778-9bd5-b224d4851d50	1	2017-10-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	TOPCARE CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [TOPCO ASSOCIATES LLC]	3
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	TOPCARE CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [TOPCO ASSOCIATES LLC]	3
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	TOPCARE CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [TOPCO ASSOCIATES LLC]	3
BUTYLPARABEN	INACTIVE INGREDIENT	3QPI1U3FV8	TOPCARE CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [TOPCO ASSOCIATES LLC]	3
CALCIUM SULFATE	INACTIVE INGREDIENT	WAT0DDB505	TOPCARE CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [TOPCO ASSOCIATES LLC]	3
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	TOPCARE CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [TOPCO ASSOCIATES LLC]	3
CARRAGEENAN	INACTIVE INGREDIENT	5C69YCD2YJ	TOPCARE CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [TOPCO ASSOCIATES LLC]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TOPCARE CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [TOPCO ASSOCIATES LLC]	3
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	TOPCARE CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [TOPCO ASSOCIATES LLC]	3
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	TOPCARE CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [TOPCO ASSOCIATES LLC]	3
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	TOPCARE CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [TOPCO ASSOCIATES LLC]	3
HIGH FRUCTOSE CORN SYRUP	INACTIVE INGREDIENT	XY6UN3QB6S	TOPCARE CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [TOPCO ASSOCIATES LLC]	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	TOPCARE CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [TOPCO ASSOCIATES LLC]	3
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	TOPCARE CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [TOPCO ASSOCIATES LLC]	3
SODIUM PHOSPHATE, TRIBASIC	INACTIVE INGREDIENT	A752Q30A6X	TOPCARE CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [TOPCO ASSOCIATES LLC]	3
SORBITOL	INACTIVE INGREDIENT	506T60A25R	TOPCARE CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [TOPCO ASSOCIATES LLC]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	TOPCARE CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [TOPCO ASSOCIATES LLC]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
36800-202	TOPCARE CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [TOPCO ASSOCIATES LLC]	10	Current NDC, Legacy NDC, 8 package rows	20241004_911492d5-e065-4b8f-b2dc-cb6a6678d0ae.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 1 of 85 · 1,692 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acetaminophen	ACETAMINOPHEN	Walgreens	543f93d1-df14-0bd2-e063-6294a90a4413	2026-08-24	Warnings	Exact identifier application number: M013
ACETAMINOPHEN	ACETAMINOPHEN	Akron Pharma Inc.	ab79fd60-8315-4c63-8045-1b0511ac268f	2026-08-24	Warnings	Exact identifier application number: M013
Genexa Infants Pain and Fever	ACETAMINOPHEN	Genexa Inc.	4fd048c3-70bc-2ea7-e063-6394a90a55f2	2026-08-22	Warnings	Exact identifier application number: M013
Genexa Kids Pain and Fever	ACETAMINOPHEN	Genexa Inc.	59adabeb-97e8-2de4-e063-6394a90acc47	2026-08-22	Warnings	Exact identifier application number: M013
Headache Relief	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Publix Super Markets Inc	a876daa7-ade3-497d-87bb-46d6e4dc185a	2026-08-21	Warnings	Exact identifier application number: M013
equate aspirin	ASPIRIN	Wal-Mart Stores Inc	ea3f8eed-7b70-4156-9586-125d27bf29a8	2026-08-19	Warnings	Exact identifier application number: M013
CARDIASPIRIN PROTECT	ASPIRIN	OPMX LLC	03774690-662b-1c30-e063-6294a90a3488	2026-08-19	Warnings	Exact identifier application number: M013
aspirin chewable, low dose	ASPIRIN	United Natural Foods, Inc. dba UNFI	6a6ac7fe-91a4-4b55-979a-b53b51505d8b	2026-08-19	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	Sam's West Inc	1098d0e7-8202-4018-a2d2-b0c80ee58b56	2026-08-19	Warnings	Exact identifier application number: M013
Headache Relief Extra Strength	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Safeway, Inc.	5e77dca4-2ff8-4a8c-94bd-f224b680ca23	2026-08-19	Warnings	Exact identifier application number: M013
dg health pain relief pm extra strength	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	Dolgencorp Inc	4d1eddf0-eff7-4c47-b312-30dee08d9e5f	2026-08-19	Warnings	Exact identifier application number: M013
Headache Formula Extra Strength	ACETAMINOPHEN, ASPIRIN, CAFFEINE	ARMY AND AIR FORCE EXCHANGE SERVICE	ee8d0961-7572-471f-8c96-b4c0bd354de2	2026-08-18	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	Rugby Laboratories	76f10ee2-1d6a-097c-e053-2991aa0af526	2026-08-18	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	Major Pharmaceuticals	780aad35-d0f1-44b1-e053-2991aa0af9a7	2026-08-18	Warnings	Exact identifier application number: M013
CHILDRENS PAIN AND FEVER	ACETAMINOPHEN	Amazon.com Services LLC	5eacbc4f-d20a-4c22-9680-4a648e24de43	2026-08-18	Warnings	Exact identifier application number: M013
Pain Relief Childrens	ACETAMINOPHEN	WinCo Foods, LLC	15921c3f-e8d4-4794-983f-63bb926f6f86	2026-08-15	Warnings	Exact identifier application number: M013
Childrens Pain plus Fever Relief	ACETAMINOPHEN	CVS PHARMACY	e4cbfb06-d826-4d08-95d6-60305c417625	2026-08-14	Warnings	Exact identifier application number: M013
Childrens Pain Relief	ACETAMINOPHEN	CVS Pharmacy,Inc.	3738d35c-1e83-40df-9292-c54e6b2c8353	2026-08-14	Warnings	Exact identifier application number: M013
CVS Childrens Pain plus Fever Relief	ACETAMINOPHEN	CVS PHARMACY	22a48a33-995b-481e-9e4e-1ad7ec346f44	2026-08-14	Warnings	Exact identifier application number: M013
Headache Relief Extra Strength	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	CVS Pharmacy	31ccc867-ca83-70a9-f3d5-5644030047b8	2026-08-13	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	911492d5-e065-4b8f-b2dc-cb6a6678d0ae	11
307668	acetaminophen 32 MG/ML Oral Suspension	SCD	911492d5-e065-4b8f-b2dc-cb6a6678d0ae	11
307668	acetaminophen 160 MG per 5 ML Oral Suspension	SY	911492d5-e065-4b8f-b2dc-cb6a6678d0ae	11
307668	acetaminophen 320 MG per 10 ML Oral Suspension	SY	911492d5-e065-4b8f-b2dc-cb6a6678d0ae	11
307668	acetaminophen 650 MG per 20.3 ML Oral Suspension	SY	911492d5-e065-4b8f-b2dc-cb6a6678d0ae	11
307668	acetaminophen 80 MG per 2.5 ML Oral Suspension	SY	911492d5-e065-4b8f-b2dc-cb6a6678d0ae	11
307668	APAP 32 MG/ML Oral Suspension	SY	911492d5-e065-4b8f-b2dc-cb6a6678d0ae	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
36800-202-00	36800020200	1 BOTTLE in 1 CARTON (36800-202-00) / 236 mL in 1 BOTTLE	1 bottle	2024-01-30		No	No	Current
36800-202-26	36800020226	1 BOTTLE in 1 CARTON (36800-202-26) / 118 mL in 1 BOTTLE	1 bottle	1992-07-20	0000-00-00	No	No	Current
36800-202-28	36800020228	1 BOTTLE in 1 CARTON (36800-202-28) > 148 mL in 1 BOTTLE	1 bottle	2013-03-08	0000-00-00	No	No	Current
36800-202-34	36800020234	2 BOTTLE in 1 CARTON (36800-202-34) > 118 mL in 1 BOTTLE	2 bottle	2017-10-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Topco Associates LLC. Children’s Pain & Fever Drug Facts	Topco Associates LLC	2025-12-13	HUMAN OTC DRUG LABEL	11