FDA.reportPublic FDA data

Pain Relief

Product NDC
49035-278
11-digit product format
490350278
Labeler code
49035
Product ID
49035-278_a330c12d-8917-4ed3-a758-735577f8c68b
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
LIQUID
Route
ORAL
Labeler
EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-12-31
Substance
ACETAMINOPHEN
Active strength
500 mg/15mL
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
Pain Relief
Brand name suffix
Extra Strength
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN500 mg/15mL

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
307684Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
872c5220-a379-4dc1-b99c-f11ebb82db35Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-278-08Pain ReliefExtra Strength237 mL in 1 BOTTLE, PLASTICLIQUID2376

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49035-278-08ML - Milliliter49035-278b6a6391a-0138-497a-ac8c-3180846a539b12018-07-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-278PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) LIQUID [EQUATE (WAL-MART STORES, INC.) (SEE ALSO WAL-MART INC)]6Current NDC, Legacy NDC, 1 package rows20240321_872c5220-a379-4dc1-b99c-f11ebb82db35.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Equaline Effervescent Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEUnited Natural Foods, Inc. dba UNFI739237a5-cc62-8ad6-e053-2991aa0a91f82024-12-17WarningsExact identifier
application number: M013
NOTTS - Muscle Aches and PainACETAMINOPHENVIVUNT PHARMA LLCe6741300-4573-2580-e053-2a95a90a599c2024-12-17WarningsExact identifier
application number: M013
Extra Strength Pain Reliever, Caseys 4goodACETAMINOPHEN 500MG, FILM-COATED CAPLETLil' Drug Store Products, Inc.e5fc5340-c224-e02b-e053-2a95a90a52972024-12-16WarningsExact identifier
application number: M013
Pain Reliever, Caseys 4goodACETAMINOPHEN 500 MG, TABLETLil' Drug Store Products, Inc.039d2cf1-57f6-4d9d-e063-6394a90a54922024-12-16WarningsExact identifier
application number: M013
Extra Strength Headache, Caseys 4goodACETAMINOPHEN, ASPIRIN, CAFFEINE TABLETLil' Drug Store Products, Inc.0425c6a8-a3ea-24ad-e063-6294a90ae15a2024-12-16WarningsExact identifier
application number: M013
Lil Drug Store Childrens Pain and FeverACETAMINOPHENLil' Drug Store Products, Inc.5fcd41ad-449f-4090-be19-eae4171de8912024-12-16WarningsExact identifier
application number: M013
Acetaminophen 250mg Aspirin 250mg Caffeine 65mgACETAMINOPHEN 250MG ASPIRIN 250MG CAFFEINE 65MGCVS Pharmacyb9e75551-1e50-9896-e053-2a95a90aafd42024-12-14WarningsExact identifier
application number: M013
Acetaminophen 250mg Aspirin 250mg Caffeine 65mgACETAMINOPHEN 250MG ASPIRIN 250MG CAFFEINE 65MGCVS Pharmacyb9e5df0e-06d3-6f72-e053-2995a90a2d072024-12-14WarningsExact identifier
application number: M013
Alka-Seltzer Heartburn and PainANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATEBayer HealthCare LLC.2928e140-c868-5bf5-e063-6394a90ab0242024-12-13WarningsExact identifier
application number: M013
foster and thrive pain relieverACETAMINOPHENStrategic Sourcing Services LLCb8ee568c-80cf-4e35-865e-35516bdab0fd2024-12-13WarningsExact identifier
application number: M013
Headache ReliefACETAMINOPHEN, ASPIRIN, CAFFEINEStrive Pharmaceuticals Inc.c0de0bd2-4868-46dc-a20f-3ca02caaa26b2024-12-11WarningsExact identifier
application number: M013
Rite Aid Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATERite Aidb4797380-9cef-d640-e053-2a95a90a06652024-12-11WarningsExact identifier
application number: M013
Top Value Effervescent Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICAROBONATETower Laboratories Ltd44babed8-cf38-1c12-e054-00144ff8d46c2024-12-11Warnings, Adverse reactionsExact identifier
application number: M013
Best Choice Effervescent Antacid Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEValu Merchandisers Companyb5e2300a-b77b-53cc-e053-2a95a90a7a6e2024-12-11WarningsExact identifier
application number: M013
EXTRA STRENGTH Headache Relief geltabsACETAMINOPHEN, ASPIRIN, CAFFEINEStrive Pharmaceuticals Inc.b432771a-4f7d-4d39-a038-d1561d8f67082024-12-11WarningsExact identifier
application number: M013
Pain Relief ChildrensACETAMINOPHENQUALITY CHOICE (Chain Drug Marketing Association)223ffb2b-3ee5-4118-955b-bc4fa4e8a2e62024-12-10WarningsExact identifier
application number: M013
acetaminophenACETAMINOPHENUNFIe689c9e3-dd4d-c646-e053-2a95a90a4b6a2024-12-09WarningsExact identifier
application number: M013
DrKids Childrens Pain and FeverACETAMINOPHEN 80MG/PIECECalmCo LLCff4b0528-39a0-80d5-e053-6394a90a8a832024-12-07WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENDISCOUNT DRUG MART972f09a7-2aa1-4b1b-a6dc-2c4578a078032024-12-05WarningsExact identifier
application number: M013
Pain Relief Extra StrengthACETAMINOPHENDISCOUNT DRUG MARTe6feff0a-3347-194d-e053-2a95a90acd202024-12-05WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307684acetaminophen 500 MG in 15 mL Oral SolutionPSN872c5220-a379-4dc1-b99c-f11ebb82db356
307684acetaminophen 33.3 MG/ML Oral SolutionSCD872c5220-a379-4dc1-b99c-f11ebb82db356
307684APAP 1000 MG per 30 ML Oral SolutionSY872c5220-a379-4dc1-b99c-f11ebb82db356
307684APAP 167 MG per 5 ML Oral SolutionSY872c5220-a379-4dc1-b99c-f11ebb82db356
307684APAP 33.3 MG/ML Oral SolutionSY872c5220-a379-4dc1-b99c-f11ebb82db356
307684APAP 500 MG per 15 ML Oral SolutionSY872c5220-a379-4dc1-b99c-f11ebb82db356

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-278-0849035027808237 mL in 1 BOTTLE, PLASTIC (49035-278-08) 237 ml2015-12-310000-00-00NoNoCurrent