FDA.reportPublic FDA data

CAREONE INFANTS ACETAMINOPHEN

Product NDC
72476-766
11-digit product format
724760766
Labeler code
72476
Product ID
72476-766_a4a04fc6-e751-41a9-8344-8da41004a960
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
SUSPENSION
Route
ORAL
Labeler
Retail Business Services, LLC
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-07-10
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
CAREONE INFANTS ACETAMINOPHEN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN160 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
307668Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b8024ec2-97c6-4aa1-b1dd-894164f48811Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72476-766-16CAREONE INFANTS ACETAMINOPHEN60 mL in 1 BOTTLESUSPENSION602
72476-766-16CAREONE INFANTS ACETAMINOPHEN1 in 1 CARTONSUSPENSION12

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 33 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EXTRA STRENGTH PAIN RELIEVERACETAMINOPHEN, ASPIRIN AND CAFFEINEGeri-Care Pharmaceutical Corpb670a898-2360-76e2-e053-2a95a90a33802025-11-17WarningsExact identifier
application number: M013
Pain Reliever PMACETAMINOPHEN, DIPHENHYDRAMINE HCLL.N.K. International, Inc.ec902e52-0f48-4a61-b67d-17e1c14616192025-11-15WarningsExact identifier
application number: M013
Pain Reliever Extra StrengthACETAMINOPHENL.N.K. International, Inc.72babe91-2586-4f05-ae90-6debfd23aa5d2025-11-15WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINStrategic Sourcing Services LLC3c7883da-6f51-4716-b012-0e33d239a60e2025-11-15WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINSam's West Inc3b84746f-05ab-4f88-b9ae-efb8c5dfc2332025-11-15WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENWalgreen Companya482e715-bec0-44a4-bb0e-ea5f5fda558e2025-11-15WarningsExact identifier
application number: M013
Acetaminophen PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLARMY AND AIR FORCE EXCHANGE SERVICEf1157dbc-d86c-4554-954c-60a74674ff6b2025-11-15WarningsExact identifier
application number: M013
Acetaminophen, Aspirin, CaffeineACETAMINOPHEN, ASPIRIN, CAFFEINENuCare Pharmaceuticals,Inc.437e4fd9-c7d9-77d6-e063-6294a90a22b72025-11-13WarningsExact identifier
application number: M013
Good Sense Pain ReliefACETAMINOPHENL. Perrigo Company7f78028a-484b-48b3-a37a-1e0b055bbefc2025-11-13WarningsExact identifier
application number: M013
OneSsip AcetaminophenACETAMINOPHENMEDWISE LIFESCIENCES INC.3f88de0f-6cf6-3580-e063-6294a90abcb42025-11-12WarningsExact identifier
application number: M013
Tylenol PM Extra StrengthACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDENavajo Manufacturing Company Inc.435b1a31-353d-af20-e063-6294a90aa9072025-11-11WarningsExact identifier
application number: M013
Good Neighbor Pharmacy Pain ReliefACETAMINOPHENAmerisource Bergen4b829607-f5fb-427f-83b5-5b6b9c44ebeb2025-11-11WarningsExact identifier
application number: M013
Pamprin Max Menstrual Pain ReliefACETAMINOPHEN AND ASPIRIN AND CAFFEINEFocus Consumer Healthcare, LLC5bd4b935-f003-7df8-e053-2a91aa0a5d792025-11-10WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENShield Pharmaceuticals Corp61e50135-a7c2-4a86-8a1a-d47b41d3f9d12025-11-07WarningsExact identifier
application number: M013
Childrens ChewablesACETAMINOPHENStrategic Sourcing Services LLCaf2cbbaf-9b73-440a-bc88-a790cafccc6b2025-11-07WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINL.N.K. International, Inc.39e142a7-8590-4e1e-8319-6904fb57cc8a2025-11-06WarningsExact identifier
application number: M013
TYLENOL Extra StrengthACETAMINOPHENKenvue Brands LLC42321456-d7dd-3b51-e063-6394a90ac2922025-11-05WarningsExact identifier
application number: M013
Childrens Pain ReliefACETAMINOPHENFamily Dollar Services Inc76058eb3-2d3f-4414-87df-7167cd27d26b2025-11-05WarningsExact identifier
application number: M013
Children Pain and Fever ReliverACETAMINOPHENTarget Corporation1116f808-f61e-47ec-b0d0-d4be5aa905be2025-11-04WarningsExact identifier
application number: M013
Pain Reliever Dye FreeACETAMINOPHENTIME CAP LABORATORIES, INC.42c4f0b2-6483-0f3c-e063-6294a90a140f2025-11-04WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSNb8024ec2-97c6-4aa1-b1dd-894164f488112
307668acetaminophen 32 MG/ML Oral SuspensionSCDb8024ec2-97c6-4aa1-b1dd-894164f488112
307668acetaminophen 160 MG per 5 ML Oral SuspensionSYb8024ec2-97c6-4aa1-b1dd-894164f488112
307668acetaminophen 320 MG per 10 ML Oral SuspensionSYb8024ec2-97c6-4aa1-b1dd-894164f488112
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSYb8024ec2-97c6-4aa1-b1dd-894164f488112
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSYb8024ec2-97c6-4aa1-b1dd-894164f488112
307668APAP 32 MG/ML Oral SuspensionSYb8024ec2-97c6-4aa1-b1dd-894164f488112

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72476-766-16724760766161 BOTTLE in 1 CARTON (72476-766-16) / 60 mL in 1 BOTTLE1 bottle2025-07-10NoNoCurrent