Pain Reliever

Product NDC
49580-2880
11-digit product format
495802880
Labeler code
49580
Product ID
49580-2880_7dfcadc9-97a1-4d12-b8d9-2053c4ee9273
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
SUSPENSION
Route
ORAL
Labeler
P & L Development, LLC
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-03-15
Marketing end
2026-12-30
Substance
ACETAMINOPHEN
Active strength
160 mg/5mL
NDC exclude flag
No
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
Pain Reliever

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
64c642b7-ef83-44b7-a014-6fa248dff3baAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49580-2880-4Pain Reliever1 in 1 BOXSUSPENSION14
49580-2880-4Pain Reliever118 mL in 1 BOTTLE, PLASTICSUSPENSION1184

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49580-2880PAIN RELIEVER (ACETAMINOPHEN) SUSPENSION [P & L DEVELOPMENT, LLC]3Current NDC, 2 package rows20240316_64c642b7-ef83-44b7-a014-6fa248dff3ba.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 78 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pain RelieverACETAMINOPHENWALGREENSf3c69974-7f51-2227-e053-2995a90a55702023-10-21WarningsExact identifier
application number: M013
Menstrual CompleteMENSTRUAL COMPLETEHealthlife of USAc7e89b01-a8eb-4487-8f0b-a4b9ae6d9f332023-10-21WarningsExact identifier
application number: M013
Extra Strength Pain ReliefACETAMINOPHENGeri-Care Pharmaceutical Corpe65dbd01-2d5e-4067-ad98-98d879cfb5ee2023-10-19WarningsExact identifier
application number: M013
Regular Strength Pain RelieverACETAMINOPHENINGLES MARKETS, INC.f06fe167-8a16-14d9-e053-2a95a90a1a0f2023-10-17WarningsExact identifier
application number: M013
Childrens Chewable AcetaminophenACETAMINOPHENBLESSINGS INTERNATIONALee8ba190-2c42-7ca2-e053-2a95a90a01a02023-10-17WarningsExact identifier
application number: M013
AphenACETAMINOPHENAsclemed USA, Inc.fe3c0a2b-316b-4620-b6bc-378dbaf7ed572023-10-16WarningsExact identifier
application number: M013
Pain Reliever Extra StrengthACETAMINOPHENWalgreensb4b06d32-6a09-4c43-980b-377b617ba7392023-10-09WarningsExact identifier
application number: M013
FLO PMS CompleteACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATEO Positiv, Inc.cce62d9f-adb1-4473-8258-910dff6b13782023-10-09WarningsExact identifier
application number: M013
childrens mapapACETAMINOPHENProficient Rx LP88c4183a-3032-46de-bf18-f700055f617b2023-10-01WarningsExact identifier
application number: M013
Tri-Buffered AspirinASPIRINProficient Rx LP640c3311-2abf-40b2-82b9-9fe4d8c1cf1d2023-10-01WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENCVS PHARMACY, INC852e70e2-7279-6f33-e053-2991aa0a86762023-08-28WarningsExact identifier
application number: M013
Children Pain ReliefCHILDREN PAIN RELIEFAllegiant Health44c90cbe-8ece-4dd8-9ea5-7f8d6f4c00962023-07-17WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINBetter Living Brands LLC4a76e898-3204-4f77-bc67-c19f5fe829f32023-07-05WarningsExact identifier
application number: M013
Aspirin Enteric CoatedASPIRIN 81 MGLodaat LLC04017bc9-602a-4204-96a9-b7f9713155f62023-01-31WarningsExact identifier
application number: M013
Aspirin 325 mgASPIRINWALGREENSd71a22e8-9e39-a672-e053-2a95a90a14032022-07-08WarningsExact identifier
application number: M013
Pain Relief Extra StrengthPAIN RELIEFAllegiant Healthd41d2319-8eed-4df9-813c-313497ceb8b42021-11-23WarningsExact identifier
application number: M013
Pain Relief PM Extra StrengthPAIN RELIEF PMAllegiant Health4c9969be-a01f-4ca4-800a-e404229ce28b2021-11-23WarningsExact identifier
application number: M013
Tension Headache ReliefTENSION HEADACHE RELIEFAllegiant Health9d348550-060b-410f-8c1e-8f43d00b860e2021-11-22WarningsExact identifier
application number: M013
Aspirin 81mg Enteric coated Low Strength Aspirin RegimenASPIRINAllegiant Health847fd2f8-2e32-4ef2-a793-b902045110f12021-11-19WarningsExact identifier
application number: M013
Aspirin 81mg Enteric coated Delayed ReleaseASPIRINAllegiant Healthd6c7c8c9-b997-4acc-a066-133bfb1239cb2021-11-02WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSN64c642b7-ef83-44b7-a014-6fa248dff3ba4
307668acetaminophen 32 MG/ML Oral SuspensionSCD64c642b7-ef83-44b7-a014-6fa248dff3ba4
307668acetaminophen 160 MG per 5 ML Oral SuspensionSY64c642b7-ef83-44b7-a014-6fa248dff3ba4
307668acetaminophen 320 MG per 10 ML Oral SuspensionSY64c642b7-ef83-44b7-a014-6fa248dff3ba4
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSY64c642b7-ef83-44b7-a014-6fa248dff3ba4
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSY64c642b7-ef83-44b7-a014-6fa248dff3ba4
307668APAP 32 MG/ML Oral SuspensionSY64c642b7-ef83-44b7-a014-6fa248dff3ba4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
49580-2880-4495802880041 BOTTLE, PLASTIC in 1 BOX (49580-2880-4) / 118 mL in 1 BOTTLE, PLASTIC2024-03-152026-12-30NoNoHistorical