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 38 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TYLENOL Extra Strength	ACETAMINOPHEN	Kenvue Brands LLC	ab02080a-c903-4e4a-a9f3-2b8197ed2f2b	2025-09-17	Warnings	Exact identifier application number: M013
Childrens TYLENOL	ACETAMINOPHEN	Kenvue Brands LLC	79669930-f744-4bb1-8325-b75951489b64	2025-09-17	Warnings	Exact identifier application number: M013
Pain Reliever PM Extra Strength	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	L.N.K. International, Inc.	ff199db8-c7ea-4b6e-ad8b-3ceeca883d92	2025-09-15	Warnings	Exact identifier application number: M013
Acetaminophen PM Extra Strength	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	FOODHOLD U.S.A., LLC	fdd7ce80-d6be-41b9-affd-d024cf306b50	2025-09-12	Warnings	Exact identifier application number: M013
Extra Strength Pain Reliever	ACETAMINOPHEN	INGLES MARKETS, INC.	3e89240b-0e27-fde4-e063-6394a90a779f	2025-09-11	Warnings	Exact identifier application number: M013
Aspirin 81 mg Low Dose	ASPIRIN	HEB	926fe7b6-9607-469f-912f-4019891067a9	2025-09-10	Warnings	Exact identifier application number: M013
Bayer Genuine Aspirin	ASPIRIN	Unifirst First Aid Corporation	356e4ff4-a7f1-4a50-9b86-2555e232b300	2025-09-09	Warnings	Exact identifier application number: M013
Medique at Home Aspirin	ASPIRIN	Unifirst First Aid Corporation	b5a469c1-9ab4-5bd7-e053-2995a90a86d1	2025-09-09	Warnings	Exact identifier application number: M013
Medique Products Aspirin	ASPIRIN	Unifirst First Aid Corporation	9b28fed0-a993-ca72-e053-2995a90ac7fd	2025-09-09	Warnings	Exact identifier application number: M013
Unishield Aspirin	ASPIRIN	Unishield	ba106b20-32ac-df90-e053-2995a90adaef	2025-09-09	Warnings	Exact identifier application number: M013
Medi First Pain Ache	ASPIRIN,CAFFEINE	Unifirst First Aid Corporation	e82d02d5-3e44-a8f8-e053-2a95a90a2688	2025-09-09	Warnings	Exact identifier application number: M013
Medique at Home Back Pain Relief	MAGNESIUM SALICYLATE	Unifirst First Aid Corporation	e56c4aef-fa0b-74db-e053-2a95a90a9745	2025-09-09	Warnings	Exact identifier application number: M013
Travel Savvy Aspirin	ASPIRIN	Bellegrove Medical Supply, Inc.	bae80044-ad7f-3bf5-e053-2995a90a42f9	2025-09-09	Warnings	Exact identifier application number: M013
McKesson Aspirin	ASPIRIN	McKesson Medical-Surgical	dabd741e-e11c-52c1-e053-2a95a90a91d5	2025-09-09	Warnings	Exact identifier application number: M013
Travel Savvy Non-Aspirin	ACETAMINOPHEN 325MG	Bellegrove Medical Supply, Inc.	6ab08633-5d5a-42b2-e053-2991aa0ab41a	2025-09-09	Warnings	Exact identifier application number: M013
Direct Safety Aspirin Free	ACETAMINOPHEN	Conney Safety Products, LLC	1c7369ea-46b6-407c-aa4b-048eb72ff03f	2025-09-09	Warnings	Exact identifier application number: M013
Direct Safety Extra Strength Aspirin Free	ACETAMINOPHEN	Conney Safety Products, LLC	a524c36a-38f3-4266-8f45-589e19400328	2025-09-09	Warnings	Exact identifier application number: M013
Direct Safety Aspirin	ASPIRIN	Direct Safety	ba9ba697-d3df-49d7-e053-2a95a90af406	2025-09-09	Warnings	Exact identifier application number: M013
McKesson Acetaminophen 325	ACETAMINOPHEN	McKesson Medical-Surgical, Inc.	bc2daba5-ce8b-bbda-e053-2a95a90a6f33	2025-09-09	Warnings	Exact identifier application number: M013
Uline Acetaminophen Extra Strength	ACETAMINOPHEN	Uline	90167594-0a49-2492-e053-2a95a90a1401	2025-09-09	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