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 74 of 79 · 1,576 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Extra Strength Acetaminophen PM	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE	KROGER COMPANY	2560126e-a54a-4a47-9631-a1bca42f5277	2024-01-10	Warnings	Exact identifier application number: M013
LOW DOSE ASPIRIN	ASPIRIN	A-S Medication Solutions	ee4451c9-4d0f-4373-8f64-fcc1f9dd5856	2024-01-05	Warnings	Exact identifier application number: M013
Pharbetol	ACETAMINOPHEN	Proficient Rx LP	51ba690e-d76b-41c6-a083-8bc803e1faa2	2024-01-01	Warnings	Exact identifier application number: M013
MEDI-FIRST Non-Aspirin Extra Strength	ACETAMINOPHEN	Proficient Rx LP	9071b047-5463-4f65-b775-bfb0ce066527	2024-01-01	Warnings	Exact identifier application number: M013
LOW DOSE ASPIRIN	ASPIRIN	TIME CAP LABORATORIES, INC	1acc8c1a-c746-4635-800c-de1ad758fce0	2023-12-30	Warnings	Exact identifier application number: M013
MAX Cold, Flu, and Sore Throat	ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN , PHENYLEPHRINE HCL	H E B	9b09b660-0758-48dc-84c9-26cdd2aacc03	2023-12-29	Warnings	Exact identifier application number: M013
NIGHT-TIME MULTI-SYMPTOM COLD/FLU Original	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	DeMoulas Market Basket	eb24323f-82a1-4ba3-9359-fe81571c3fba	2023-12-29	Warnings	Exact identifier application number: M013
Nite-TimeCOLD/FLU CHERRY COLD/FLU CHERRY	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Salado Sales, Inc.	e6c3e545-b2ad-47f0-8318-c134a8e24f5b	2023-12-29	Warnings	Exact identifier application number: M013
Daytime Non-Drowsy COLD/FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Salado Sales, Inc.	e181b371-78c7-4163-865d-acc064be33ca	2023-12-29	Warnings	Exact identifier application number: M013
Childrens Pain and Fever Cherry flavor	ACETAMINOPHEN	Walgreen Company	64c65244-f7a3-401b-b83a-bf66d45268e2	2023-12-29	Warnings	Exact identifier application number: M013
Nite-Time COLD/FLU ORIGINAL	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Salado Sales, Inc.	fcd24753-b42b-4d05-8379-0ec0351ab217	2023-12-29	Warnings	Exact identifier application number: M013
NIGHT-TIME MULTI-SYMPTOM COLD/FLU Cherry	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	DeMoulas Market Basket	e772cdf5-d01d-4752-8cfb-7e7f4d7a8dd0	2023-12-29	Warnings	Exact identifier application number: M013
Childrens Pain and Fever, Grape flavor	ACETAMINOPHEN	Walgreen Company	0995d69f-61aa-40b0-b095-bb8595caf773	2023-12-29	Warnings	Exact identifier application number: M013
DAY-TIME Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	DeMoulas Market Basket	ce900e42-d0c8-408d-a1c3-3a9bef1c97ee	2023-12-29	Warnings	Exact identifier application number: M013
Pain Relief PM	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	DOLGENCORP, INC.	06553550-5685-f3c3-e063-6394a90aef07	2023-12-22	Warnings	Exact identifier application number: M013
Tension Headache Pain Relieving Aid	ACETAMINOPHEN,CAFFEINE	WAL-MART STORES INC	00fadd26-a6eb-dc5e-e063-6394a90a3cca	2023-12-15	Warnings	Exact identifier application number: M013
Dye-Free Aspirin 81	ASPIRIN	WALGREENS	d71a9d3a-cd28-14a8-e053-2995a90a832b	2023-12-15	Warnings	Exact identifier application number: M013
Lil Drug Store Aspirin 325	ASPIRIN	Lil Drug Store Products, Inc	de59aae2-f794-4243-acc8-37a10e27abde	2023-12-15	Warnings	Exact identifier application number: M013
Pain Reliever	ACETAMINOPHEN TABLET, EXTRA STRENGTH	Lil' Drug Store Products, Inc.	f0fdab5a-9d07-57aa-e053-2a95a90adc7f	2023-12-15	Warnings	Exact identifier application number: M013
BC Cherry	ASPIRIN AND CAFFEINE	Lil' Drug Store Products, Inc	79ea721b-d656-44f7-9d13-390debee7be0	2023-12-15	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