FDA.reportPublic FDA data

Pharbetol

Product NDC
73057-376
11-digit product format
730570376
Labeler code
73057
Product ID
73057-376_2b899f07-4c46-cd87-e063-6294a90a4090
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen 500mg
Dosage form
TABLET
Route
ORAL
Labeler
Ulai Health LLC
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-07-08
Substance
ACETAMINOPHEN
Active strength
500 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 3 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct73057-376UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage73057-37673057-376-11UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage73057-37673057-376-08UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…

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
Pharbetol
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN500 mg/1

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198440Internal RxNorm lookup
1293942Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e64ce7b1-4501-4b51-b012-1882ed153b42Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
73057-376-082022-01-31Drug Facts
73057-376-112022-01-31Drug Facts
73057-376-082022-01-28Drug Facts
73057-376-112022-01-28Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73057-376-08Pharbetol100 in 1 BOTTLE, PLASTICTABLET1003
73057-376-11Pharbetol1000 in 1 BOTTLE, PLASTICTABLET10003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73057-376PHARBETOL (ACETAMINOPHEN 500MG) TABLET [ULAI HEALTH LLC]3Current NDC, Legacy NDC, 2 package rows20250114_e64ce7b1-4501-4b51-b012-1882ed153b42.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 38 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TYLENOL Extra StrengthACETAMINOPHENKenvue Brands LLCab02080a-c903-4e4a-a9f3-2b8197ed2f2b2025-09-17WarningsExact identifier
application number: M013
Childrens TYLENOLACETAMINOPHENKenvue Brands LLC79669930-f744-4bb1-8325-b75951489b642025-09-17WarningsExact identifier
application number: M013
Pain Reliever PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLL.N.K. International, Inc.ff199db8-c7ea-4b6e-ad8b-3ceeca883d922025-09-15WarningsExact identifier
application number: M013
Acetaminophen PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLFOODHOLD U.S.A., LLCfdd7ce80-d6be-41b9-affd-d024cf306b502025-09-12WarningsExact identifier
application number: M013
Extra Strength Pain RelieverACETAMINOPHENINGLES MARKETS, INC.3e89240b-0e27-fde4-e063-6394a90a779f2025-09-11WarningsExact identifier
application number: M013
Aspirin 81 mg Low DoseASPIRINHEB926fe7b6-9607-469f-912f-4019891067a92025-09-10WarningsExact identifier
application number: M013
Bayer Genuine AspirinASPIRINUnifirst First Aid Corporation356e4ff4-a7f1-4a50-9b86-2555e232b3002025-09-09WarningsExact identifier
application number: M013
Medique at Home AspirinASPIRINUnifirst First Aid Corporationb5a469c1-9ab4-5bd7-e053-2995a90a86d12025-09-09WarningsExact identifier
application number: M013
Medique Products AspirinASPIRINUnifirst First Aid Corporation9b28fed0-a993-ca72-e053-2995a90ac7fd2025-09-09WarningsExact identifier
application number: M013
Unishield AspirinASPIRINUnishieldba106b20-32ac-df90-e053-2995a90adaef2025-09-09WarningsExact identifier
application number: M013
Medi First Pain AcheASPIRIN,CAFFEINEUnifirst First Aid Corporatione82d02d5-3e44-a8f8-e053-2a95a90a26882025-09-09WarningsExact identifier
application number: M013
Medique at Home Back Pain ReliefMAGNESIUM SALICYLATEUnifirst First Aid Corporatione56c4aef-fa0b-74db-e053-2a95a90a97452025-09-09WarningsExact identifier
application number: M013
Travel Savvy AspirinASPIRINBellegrove Medical Supply, Inc.bae80044-ad7f-3bf5-e053-2995a90a42f92025-09-09WarningsExact identifier
application number: M013
McKesson AspirinASPIRINMcKesson Medical-Surgicaldabd741e-e11c-52c1-e053-2a95a90a91d52025-09-09WarningsExact identifier
application number: M013
Travel Savvy Non-AspirinACETAMINOPHEN 325MGBellegrove Medical Supply, Inc.6ab08633-5d5a-42b2-e053-2991aa0ab41a2025-09-09WarningsExact identifier
application number: M013
Direct Safety Aspirin FreeACETAMINOPHENConney Safety Products, LLC1c7369ea-46b6-407c-aa4b-048eb72ff03f2025-09-09WarningsExact identifier
application number: M013
Direct Safety Extra Strength Aspirin FreeACETAMINOPHENConney Safety Products, LLCa524c36a-38f3-4266-8f45-589e194003282025-09-09WarningsExact identifier
application number: M013
Direct Safety AspirinASPIRINDirect Safetyba9ba697-d3df-49d7-e053-2a95a90af4062025-09-09WarningsExact identifier
application number: M013
McKesson Acetaminophen 325ACETAMINOPHENMcKesson Medical-Surgical, Inc.bc2daba5-ce8b-bbda-e053-2a95a90a6f332025-09-09WarningsExact identifier
application number: M013
Uline Acetaminophen Extra StrengthACETAMINOPHENUline90167594-0a49-2492-e053-2a95a90a14012025-09-09WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSNe64ce7b1-4501-4b51-b012-1882ed153b423
1293942Pharbetol 500 MG Oral TabletPSNe64ce7b1-4501-4b51-b012-1882ed153b423
1293942acetaminophen 500 MG Oral Tablet [Pharbetol]SBDe64ce7b1-4501-4b51-b012-1882ed153b423
198440acetaminophen 500 MG Oral TabletSCDe64ce7b1-4501-4b51-b012-1882ed153b423
198440APAP 500 MG Oral TabletSYe64ce7b1-4501-4b51-b012-1882ed153b423
1293942APAP 500 MG Oral Tablet [Pharbetol]SYe64ce7b1-4501-4b51-b012-1882ed153b423
1293942Pharbetol 500 MG Oral TabletSYe64ce7b1-4501-4b51-b012-1882ed153b423

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
73057-376-0873057037608100 TABLET in 1 BOTTLE, PLASTIC (73057-376-08) 100 tablet2019-07-080000-00-00NoNoCurrent
73057-376-11730570376111000 TABLET in 1 BOTTLE, PLASTIC (73057-376-11) 1000 tablet2019-07-080000-00-00NoNoCurrent