topcare infants pain and fever

Product NDC: 36800-766
11-digit product format: 368000766
Labeler code: 36800
Product ID: 36800-766_21472a62-d6a7-438b-a5e4-c2845d8ffe13
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: 2011-11-03
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
a1145ac3-3e55-4bd5-a53e-6cf869add9a1	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
36800-766-16	topcare infants pain and fever	59 mL in 1 BOTTLE	SUSPENSION	59		7
36800-766-16	topcare infants pain and fever	1 in 1 CARTON	SUSPENSION	1		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
36800-766-16	ML - Milliliter	36800-766	bdf1d581-4ee0-4d70-9b3e-89f88091630d	1	2012-07-24

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
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
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	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
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	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
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	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
36800-766	TOPCARE INFANTS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [TOPCO ASSOCIATES LLC]	7	Current NDC, Legacy NDC, 2 package rows	20240726_a1145ac3-3e55-4bd5-a53e-6cf869add9a1.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 72 of 79 · 1,576 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Excedrin Tension Headache	ACETAMINOPHEN, CAFFEINE	Haleon US Holdings LLC	12c074d1-81ac-47d2-8747-b018cda0058a	2024-03-13	Warnings	Exact identifier application number: M013
Menstrual Complete	ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE	Strive Pharmaceuticals Inc.	78c12459-3b27-4ed0-943d-520794eb438d	2024-03-07	Warnings	Exact identifier application number: M013
Pain Reliever fever Reducer Extra Strength	ACETAMINOPHEN	CVS Pharmacy	7b5263ad-01b7-4fc5-9384-4da8efe89e35	2024-03-06	Warnings	Exact identifier application number: M013
Excedrin Extra Strength Geltabs	ACETAMINOPHEN, ASPRIN, CAFFEINE	Haleon US Holdings LLC	11a8439b-0159-4351-b0f5-fe7fad6a33c0	2024-03-05	Warnings	Exact identifier application number: M013
Winco Foods Effervescent Pain Relief	ASPIRIN	Winco Foods, LLC	128afdd7-a9d1-8957-e063-6294a90af569	2024-03-05	Warnings	Exact identifier application number: M013
Aspirin Low Dose Safety Coated	ASPIRIN	Care One (Retail Business Services, LLC.)	6659e103-fa03-4de0-af42-d2fbd548a87c	2024-03-05	Warnings	Exact identifier application number: M013
Dolex Children Pain and Fever	ACETAMINOPHEN	Pharmadel LLC	f9158463-aeb1-5de0-e053-6294a90a748b	2024-03-04	Warnings	Exact identifier application number: M013
SEDALMEX FORTE	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Belmora LLC	33b3508e-4caa-4d05-9b15-cb82a2ee2d4d	2024-02-28	Warnings	Exact identifier application number: M013
Pain Relief	ACETAMINOPHEN	AMERISOURCE BERGEN	2b923a97-836c-4dac-a8c0-3047a35fb62e	2024-02-23	Warnings	Exact identifier application number: M013
Pain Reliever PM Extra Strength	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	BJWC (Berkley & Jensen / BJ's)	b20a08f3-c9c0-4bd9-8ce0-acb932b5bb86	2024-02-22	Warnings	Exact identifier application number: M013
M-PAP	ACETAMINOPHEN	Bryant Ranch Prepack	31a41976-7f65-42d7-acf5-de9c2c5ca58e	2024-02-20	Warnings	Exact identifier application number: M013
Publix Fast Relief Effervescent - Original Flavor	ASPIRIN	PUBLIX SUPER MARKETS INC.	0a342f72-45fd-3e12-e063-6394a90ae33e	2024-02-16	Warnings	Exact identifier application number: M013
Equaline Effervescent Pain Reliever	ASPIRIN	UNITED NATURAL FOODS, INC. DBA UNFI	0761299a-e913-7665-e063-6394a90a6003	2024-02-16	Warnings	Exact identifier application number: M013
TopCare Effervescent Pain Relief	ASPIRIN	TOPCO ASSOCIATES LLC	075f36e1-110c-e839-e063-6294a90a89d7	2024-02-16	Warnings	Exact identifier application number: M013
Extra Strength Pain Reliever	ACETAMINOPHEN	INGLES MARKETS, INC.	115d0b4f-6f0f-79a9-e063-6394a90ab18a	2024-02-14	Warnings	Exact identifier application number: M013
PANADOL	ACETAMINOPHEN	Haleon US Holdings LLC	e1799765-c247-42b4-ad6a-8ba7d136abf2	2024-02-06	Warnings	Exact identifier application number: M013
Panadol Cold and Flu NonDrowsy	ACETAMINOPHEN AND PHENYLEPRINE HCL	Haleon US Holdings LLC	f626ab17-01c9-4493-ba9e-0c8c11146384	2024-02-06	Warnings	Exact identifier application number: M013
PANADOL Extra	ACETAMINOPHEN AND CAFFEINE	Haleon US Holdings LLC	e5c2d88a-d903-4ca0-b895-f27e791dfc4e	2024-02-06	Warnings	Exact identifier application number: M013
PANADOL Extra Strength	ACETAMINOPHEN	Haleon US Holdings LLC	b2fe7f47-1a2e-40ee-8f8f-38f2028dce1b	2024-02-06	Warnings	Exact identifier application number: M013
PANADOL Extra Strength	ACETAMINOPHEN	Haleon US Holdings LLC	9d384e88-5c11-4600-ac6c-a38371570138	2024-02-06	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	a1145ac3-3e55-4bd5-a53e-6cf869add9a1	7
307668	acetaminophen 32 MG/ML Oral Suspension	SCD	a1145ac3-3e55-4bd5-a53e-6cf869add9a1	7
307668	acetaminophen 160 MG per 5 ML Oral Suspension	SY	a1145ac3-3e55-4bd5-a53e-6cf869add9a1	7
307668	acetaminophen 320 MG per 10 ML Oral Suspension	SY	a1145ac3-3e55-4bd5-a53e-6cf869add9a1	7
307668	acetaminophen 650 MG per 20.3 ML Oral Suspension	SY	a1145ac3-3e55-4bd5-a53e-6cf869add9a1	7
307668	acetaminophen 80 MG per 2.5 ML Oral Suspension	SY	a1145ac3-3e55-4bd5-a53e-6cf869add9a1	7
307668	APAP 32 MG/ML Oral Suspension	SY	a1145ac3-3e55-4bd5-a53e-6cf869add9a1	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
36800-766-16	36800076616	1 BOTTLE in 1 CARTON (36800-766-16) / 59 mL in 1 BOTTLE	1 bottle	2011-11-03	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	2024-07-02	HUMAN OTC DRUG LABEL	7