FDA.reportPublic FDA data

Childrens Pain and Fever

Product NDC
76281-526
11-digit product format
762810526
Labeler code
76281
Product ID
76281-526_5b15b381-438f-403f-8db3-ac8576244ea0
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN
Dosage form
SUSPENSION
Route
ORAL
Labeler
AptaPharma Inc.
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-08-21
Substance
ACETAMINOPHEN
Active strength
160 mg/5mL
NDC exclude flag
No
Listing certified through
2027-12-31
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
Childrens Pain and Fever
Listing expiration
2027-12-31

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
9064943f-836f-4853-b6f2-2c4879941eebAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76281-526-23Childrens Pain and Fever59 mL in 1 BOTTLESUSPENSION593
76281-526-23Childrens Pain and Fever1 in 1 CARTONSUSPENSION13
76281-526-24Childrens Pain and Fever1 in 1 CARTONSUSPENSION13
76281-526-24Childrens Pain and Fever118 mL in 1 BOTTLESUSPENSION1183

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76281-526CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [APTAPHARMA INC.]3Current NDC, Legacy NDC, 4 package rows20240203_9064943f-836f-4853-b6f2-2c4879941eeb.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 61 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Chewable AspirinASPIRINRETAIL BUSINESS SERVICES , LLC.c94d68ea-7f25-881f-e053-2995a90aa47f2024-10-15WarningsExact identifier
application number: M013
LOW DOSE ASPIRINASPIRINRETAIL BUSINESS SERVICES , LLC.c94d750e-5a85-77f5-e053-2995a90a69152024-10-15WarningsExact identifier
application number: M013
Infants Pain and FeverACETAMINOPHENWalgreen Company9e08eb38-7538-4fa0-a0e1-047ab6cb16802024-10-15WarningsExact identifier
application number: M013
pain reliefACETAMINOPHENPUBLIX SUPER MARKETS INC9e779cc6-4641-6132-e053-2a95a90a34932024-10-11WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENCHAIN DRUG CONSORTIUM5c1a3081-ae25-4895-bf76-ebcbb9fc80722024-10-11WarningsExact identifier
application number: M013
Aspirin 81 MGASPIRINMeijerb3e5711c-9529-4eec-871d-de8efa858b862024-10-11WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENMEIJER DISTRIBUTION INC9586e830-a285-4a07-8b34-9698754423482024-10-11WarningsExact identifier
application number: M013
Pain Relief Extra StrengthACETAMINOPHENChain Drug Marketing Association68a52858-35c5-402a-8ceb-8d8a7c1e5f6c2024-10-11WarningsExact identifier
application number: M013
Pain Relief Extra StrengthACETAMINOPHENChain Drug Marketing Association5de40821-3218-4320-bf11-9493bf01d4892024-10-11WarningsExact identifier
application number: M013
Pain Relief PM Extra StrengthACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEChain Drug Marketing Association475becec-1a56-4cfa-a0c5-562f8772adfb2024-10-11WarningsExact identifier
application number: M013
Topcare Pain ReliefACETAMINOPHENTopco Associates LLC6036c15b-1168-4103-9471-6a74a2140e532024-10-10WarningsExact identifier
application number: M013
Childrens AcetaminophenACETAMINOPHENPAI Holdings, LLC dba PAI Pharma46d9d8cd-e3db-492c-9386-7e8255beff642024-10-08WarningsExact identifier
application number: M013
dg health aspirinASPIRINDolgencorp, LLC0ab34dc7-0110-4fc3-ae53-234e7d7bca3c2024-10-07WarningsExact identifier
application number: M013
ValuMeds Pain Relief PM Pain Reliever and Nighttime Sleep Aid Acetaminophen, Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDECabinet Health P.B.C.19ba1fb6-22ea-488e-9e52-94c14ceb80d12024-10-07WarningsExact identifier
application number: M013
foster and thrive aspirinASPIRINStrategic Sourcing Services LLC4d66a8a8-a1c1-4430-8845-21ae67700c392024-10-07WarningsExact identifier
application number: M013
leader aspirinASPIRINCardinal Health 110, LLC. dba Leaderca603b12-e0f7-4d79-8e0d-4651a788ba9b2024-10-07WarningsExact identifier
application number: M013
foster and thrive aspirinASPIRINMcKesson Medical-Surgical, Inc.e9342478-93d6-45de-948f-f4162ee675b22024-10-07WarningsExact identifier
application number: M013
Maximum Strength Backache ReliefMAGNESIUM SALICYLATEJHK DBA American Safety & First Aidf8cbcd4e-cfad-4592-8774-52e681494c452024-10-07WarningsExact identifier
application number: M013
Alka-Seltzer Original FlavorALKA-SELTZER ORIGINAL FLAVORNavajo Manufacturing Company Inc.f70875ab-241c-4876-e053-6294a90a80922024-10-03WarningsExact identifier
application number: M013
Tylenol Extra StrengthACETAMINOPHENNavajo Manufacturing Company Inc.86b6ac01-3866-4cd8-a1be-9babb6ff311b2024-10-02WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSN9064943f-836f-4853-b6f2-2c4879941eeb3
307668acetaminophen 32 MG/ML Oral SuspensionSCD9064943f-836f-4853-b6f2-2c4879941eeb3
307668acetaminophen 160 MG per 5 ML Oral SuspensionSY9064943f-836f-4853-b6f2-2c4879941eeb3
307668acetaminophen 320 MG per 10 ML Oral SuspensionSY9064943f-836f-4853-b6f2-2c4879941eeb3
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSY9064943f-836f-4853-b6f2-2c4879941eeb3
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSY9064943f-836f-4853-b6f2-2c4879941eeb3
307668APAP 32 MG/ML Oral SuspensionSY9064943f-836f-4853-b6f2-2c4879941eeb3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76281-526-23762810526231 BOTTLE in 1 CARTON (76281-526-23) / 59 mL in 1 BOTTLE1 bottle2024-01-30NoNoCurrent
76281-526-24762810526241 BOTTLE in 1 CARTON (76281-526-24) / 118 mL in 1 BOTTLE1 bottle2020-09-300000-00-00NoNoCurrent