topcare infants pain and fever

Product NDC: 36800-946
11-digit product format: 368000946
Labeler code: 36800
Product ID: 36800-946_97a41218-6179-415d-ade1-2a94ae4e1f7d
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: 2011-08-24
Substance: ACETAMINOPHEN
Active strength: 160 mg/5mL
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 infants 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
f1e940ef-3cf0-4a5c-8158-156d0e5a680d	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
36800-946-10	topcare infants pain and fever	1 in 1 CARTON	SUSPENSION	1	8
36800-946-10	topcare infants pain and fever	30 mL in 1 BOTTLE, DROPPER	SUSPENSION	30	8
36800-946-16	topcare infants pain and fever	59 mL in 1 BOTTLE, DROPPER	SUSPENSION	59	8
36800-946-16	topcare infants pain and fever	1 in 1 CARTON	SUSPENSION	1	8

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	TOPCARE INFANTS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [TOPCO ASSOCIATES LLC]	3
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	TOPCARE INFANTS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [TOPCO ASSOCIATES LLC]	3
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	TOPCARE INFANTS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [TOPCO ASSOCIATES LLC]	3
BUTYLPARABEN	INACTIVE INGREDIENT	3QPI1U3FV8	TOPCARE INFANTS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [TOPCO ASSOCIATES LLC]	3
CALCIUM SULFATE	INACTIVE INGREDIENT	WAT0DDB505	TOPCARE INFANTS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [TOPCO ASSOCIATES LLC]	3
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	TOPCARE INFANTS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [TOPCO ASSOCIATES LLC]	3
CARRAGEENAN	INACTIVE INGREDIENT	5C69YCD2YJ	TOPCARE INFANTS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [TOPCO ASSOCIATES LLC]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TOPCARE INFANTS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [TOPCO ASSOCIATES LLC]	3
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	TOPCARE INFANTS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [TOPCO ASSOCIATES LLC]	3
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	TOPCARE INFANTS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [TOPCO ASSOCIATES LLC]	3
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	TOPCARE INFANTS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [TOPCO ASSOCIATES LLC]	3
HIGH FRUCTOSE CORN SYRUP	INACTIVE INGREDIENT	XY6UN3QB6S	TOPCARE INFANTS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [TOPCO ASSOCIATES LLC]	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	TOPCARE INFANTS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [TOPCO ASSOCIATES LLC]	3
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	TOPCARE INFANTS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [TOPCO ASSOCIATES LLC]	3
SODIUM PHOSPHATE, TRIBASIC	INACTIVE INGREDIENT	A752Q30A6X	TOPCARE INFANTS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [TOPCO ASSOCIATES LLC]	3
SORBITOL	INACTIVE INGREDIENT	506T60A25R	TOPCARE INFANTS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [TOPCO ASSOCIATES LLC]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	TOPCARE INFANTS 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
36800-946	TOPCARE INFANTS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [TOPCO ASSOCIATES LLC]	8	Current NDC, Legacy NDC, 4 package rows	20240711_f1e940ef-3cf0-4a5c-8158-156d0e5a680d.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 57 of 79 · 1,576 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
foster and thrive pain reliever	ACETAMINOPHEN	Strategic Sourcing Services LLC	338021bd-b92b-45eb-a4b8-bc4a100ab718	2024-11-06	Warnings	Exact identifier application number: M013
basic care headache relief	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Amazon.com Services LLC	f85d2f4c-8184-4555-a310-3979722e860b	2024-11-05	Warnings	Exact identifier application number: M013
MENSTRUAL COMPLETE	MENSTRUAL COMPLETE	Allegiant Health	d197b886-67e4-4aba-8582-305576c07604	2024-11-05	Warnings	Exact identifier application number: M013
dg health headache relief	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Dolgencorp Inc	ddf40cc4-d73f-4460-be72-9486134329a7	2024-11-05	Warnings	Exact identifier application number: M013
DOLO- NeuroBion Acetaminophen 500mg	ACETAMINOPHEN	BENARD INDUSTRIES INC	16f8415d-8190-4212-b487-c0caf7d3bee2	2024-11-04	Warnings	Exact identifier application number: M013
basic care acetaminophen	ACETAMINOPHEN	Amazon.com Services LLC	8c3343ee-d7b6-496d-9702-6736539a7270	2024-11-02	Warnings	Exact identifier application number: M013
dg health pain relief	ACETAMINOPHEN	Dolgencorp, LLC	382fa2cc-1c39-4bee-b528-08b11ec945af	2024-11-02	Warnings	Exact identifier application number: M013
acetaminophen	ACETAMINOPHEN	Bryant Ranch Prepack	f7e20527-1d4b-434c-997b-3eb8211fdaa1	2024-11-01	Warnings	Exact identifier application number: M013
Aspirin Enteric Safety Coated	ASPIRIN	Publix Supermarkets, Inc.	a661a9ed-9b31-46b1-aafb-61d1ba8a4918	2024-11-01	Warnings	Exact identifier application number: M013
acetaminophen	ACETAMINOPHEN	Bryant Ranch Prepack	614e69c7-d3cb-4d47-9603-c1c14b87544c	2024-11-01	Warnings	Exact identifier application number: M013
infants fever reducer and pain reliever	ACETAMINOPHEN	Rite Aid Corporation	baee03b8-fcfd-440e-90ea-1ee2a18516ef	2024-11-01	Warnings	Exact identifier application number: M013
good neighbor pharmacy infants pain and fever	ACETAMINOPHEN	Amerisource Bergen	bfb954b7-3a79-4bca-95e8-d39e1074b07f	2024-11-01	Warnings	Exact identifier application number: M013
EXTRA STRENGTH PAIN RELIEVER	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	Proficient Rx LP	bf365bfc-35cc-47f9-a50b-ff2b38d7316b	2024-11-01	Warnings	Exact identifier application number: M013
Infants Pain Relief	ACETAMINOPHEN	Publix Super Markets Inc	0bc33897-afc2-4d11-be6c-a26480f448bf	2024-10-31	Warnings	Exact identifier application number: M013
equate infants pain and fever	ACETAMINOPHEN	WALMART INC.	34b2512e-743b-45db-92cb-ea05e2f47b3d	2024-10-31	Warnings	Exact identifier application number: M013
foster and thrive infants pain and fever	ACETAMINOPHEN	Strategic Sourcing Services LLC	45770ad6-9bf7-41bd-a724-e5260cd31fa1	2024-10-31	Warnings	Exact identifier application number: M013
Midol Complete	ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE TABLET	Lil' Drug Store Products, Inc.	d20425a4-f074-4154-e053-2995a90ae9fd	2024-10-30	Warnings	Exact identifier application number: M013
up and up infants acetaminophen	ACETAMINOPHEN	Target Corporation	31104956-04d7-41b5-82be-219ded5c02a9	2024-10-30	Warnings	Exact identifier application number: M013
Sunmark Aspirin	ASPIRIN	Strategic Sourcing Services LLC	a7139686-b351-47dc-a395-832429aaa569	2024-10-30	Warnings	Exact identifier application number: M013
Good Neighbor Pharmacy Pain Relief	ACETAMINOPHEN	Amerisource Bergen	5101125d-4819-4e4b-a0ee-a0ff8d5a0ab1	2024-10-30	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	f1e940ef-3cf0-4a5c-8158-156d0e5a680d	8
307668	acetaminophen 32 MG/ML Oral Suspension	SCD	f1e940ef-3cf0-4a5c-8158-156d0e5a680d	8
307668	acetaminophen 160 MG per 5 ML Oral Suspension	SY	f1e940ef-3cf0-4a5c-8158-156d0e5a680d	8
307668	acetaminophen 320 MG per 10 ML Oral Suspension	SY	f1e940ef-3cf0-4a5c-8158-156d0e5a680d	8
307668	acetaminophen 650 MG per 20.3 ML Oral Suspension	SY	f1e940ef-3cf0-4a5c-8158-156d0e5a680d	8
307668	acetaminophen 80 MG per 2.5 ML Oral Suspension	SY	f1e940ef-3cf0-4a5c-8158-156d0e5a680d	8
307668	APAP 32 MG/ML Oral Suspension	SY	f1e940ef-3cf0-4a5c-8158-156d0e5a680d	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
36800-946-10	36800094610	1 BOTTLE, DROPPER in 1 CARTON (36800-946-10) / 30 mL in 1 BOTTLE, DROPPER	2011-08-24	0000-00-00	No	No	Current
36800-946-16	36800094616	1 BOTTLE, DROPPER in 1 CARTON (36800-946-16) / 59 mL in 1 BOTTLE, DROPPER	2011-08-24	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Topco Associates LLC. Infants' Pain & Fever Drug Facts	Topco Associates LLC	2024-06-13	HUMAN OTC DRUG LABEL	8