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 52 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Equaline Effervescent Antacid and Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	United Natural Foods, Inc. dba UNFI	739237a5-cc62-8ad6-e053-2991aa0a91f8	2024-12-17	Warnings	Exact identifier application number: M013
NOTTS - Muscle Aches and Pain	ACETAMINOPHEN	VIVUNT PHARMA LLC	e6741300-4573-2580-e053-2a95a90a599c	2024-12-17	Warnings	Exact identifier application number: M013
Extra Strength Pain Reliever, Caseys 4good	ACETAMINOPHEN 500MG, FILM-COATED CAPLET	Lil' Drug Store Products, Inc.	e5fc5340-c224-e02b-e053-2a95a90a5297	2024-12-16	Warnings	Exact identifier application number: M013
Pain Reliever, Caseys 4good	ACETAMINOPHEN 500 MG, TABLET	Lil' Drug Store Products, Inc.	039d2cf1-57f6-4d9d-e063-6394a90a5492	2024-12-16	Warnings	Exact identifier application number: M013
Extra Strength Headache, Caseys 4good	ACETAMINOPHEN, ASPIRIN, CAFFEINE TABLET	Lil' Drug Store Products, Inc.	0425c6a8-a3ea-24ad-e063-6294a90ae15a	2024-12-16	Warnings	Exact identifier application number: M013
Lil Drug Store Childrens Pain and Fever	ACETAMINOPHEN	Lil' Drug Store Products, Inc.	5fcd41ad-449f-4090-be19-eae4171de891	2024-12-16	Warnings	Exact identifier application number: M013
Acetaminophen 250mg Aspirin 250mg Caffeine 65mg	ACETAMINOPHEN 250MG ASPIRIN 250MG CAFFEINE 65MG	CVS Pharmacy	b9e75551-1e50-9896-e053-2a95a90aafd4	2024-12-14	Warnings	Exact identifier application number: M013
Acetaminophen 250mg Aspirin 250mg Caffeine 65mg	ACETAMINOPHEN 250MG ASPIRIN 250MG CAFFEINE 65MG	CVS Pharmacy	b9e5df0e-06d3-6f72-e053-2995a90a2d07	2024-12-14	Warnings	Exact identifier application number: M013
Alka-Seltzer Heartburn and Pain	ANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATE	Bayer HealthCare LLC.	2928e140-c868-5bf5-e063-6394a90ab024	2024-12-13	Warnings	Exact identifier application number: M013
foster and thrive pain reliever	ACETAMINOPHEN	Strategic Sourcing Services LLC	b8ee568c-80cf-4e35-865e-35516bdab0fd	2024-12-13	Warnings	Exact identifier application number: M013
Headache Relief	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Strive Pharmaceuticals Inc.	c0de0bd2-4868-46dc-a20f-3ca02caaa26b	2024-12-11	Warnings	Exact identifier application number: M013
Rite Aid Antacid and Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Rite Aid	b4797380-9cef-d640-e053-2a95a90a0665	2024-12-11	Warnings	Exact identifier application number: M013
Top Value Effervescent Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICAROBONATE	Tower Laboratories Ltd	44babed8-cf38-1c12-e054-00144ff8d46c	2024-12-11	Warnings, Adverse reactions	Exact identifier application number: M013
Best Choice Effervescent Antacid Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Valu Merchandisers Company	b5e2300a-b77b-53cc-e053-2a95a90a7a6e	2024-12-11	Warnings	Exact identifier application number: M013
EXTRA STRENGTH Headache Relief geltabs	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Strive Pharmaceuticals Inc.	b432771a-4f7d-4d39-a038-d1561d8f6708	2024-12-11	Warnings	Exact identifier application number: M013
Pain Relief Childrens	ACETAMINOPHEN	QUALITY CHOICE (Chain Drug Marketing Association)	223ffb2b-3ee5-4118-955b-bc4fa4e8a2e6	2024-12-10	Warnings	Exact identifier application number: M013
acetaminophen	ACETAMINOPHEN	UNFI	e689c9e3-dd4d-c646-e053-2a95a90a4b6a	2024-12-09	Warnings	Exact identifier application number: M013
DrKids Childrens Pain and Fever	ACETAMINOPHEN 80MG/PIECE	CalmCo LLC	ff4b0528-39a0-80d5-e053-6394a90a8a83	2024-12-07	Warnings	Exact identifier application number: M013
Pain Relief	ACETAMINOPHEN	DISCOUNT DRUG MART	972f09a7-2aa1-4b1b-a6dc-2c4578a07803	2024-12-05	Warnings	Exact identifier application number: M013
Pain Relief Extra Strength	ACETAMINOPHEN	DISCOUNT DRUG MART	e6feff0a-3347-194d-e053-2a95a90acd20	2024-12-05	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