FDA.reportPublic FDA data

Pharbetol

Product NDC
71205-990
11-digit product format
712050990
Labeler code
71205
Product ID
71205-990_7429cee4-9642-4421-b4b6-4f942fc4df36
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2006-01-10
Substance
ACETAMINOPHEN
Active strength
500 mg/1
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
Pharbetol
Listing expiration
2027-12-31

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 SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9c7d65e4-df2f-47c1-a185-66aaf19aad2bAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71205-990-00Pharbetol100 in 1 BOTTLE, PLASTICTABLET1004
71205-990-11Pharbetol1000 in 1 BOTTLE, PLASTICTABLET10004
71205-990-50Pharbetol50 in 1 BOTTLE, PLASTICTABLET504
71205-990-55Pharbetol500 in 1 BOTTLE, PLASTICTABLET5004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-990-00EA - Each71205-9901f3fb118-7123-4d07-bcf6-5eea597a352012021-06-02
71205-990-11EA - Each71205-990b6fdcf31-5e5c-40fd-949a-d091d9322ae612021-06-02
71205-990-50EA - Each71205-990f3a2e822-a5a3-4d9b-9642-244d36dfa5cf12021-06-02
71205-990-55EA - Each71205-990630f8edb-00e3-4eb3-9f75-89ca7a9f851012021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-990PHARBETOL (ACETAMINOPHEN) TABLET [PROFICIENT RX LP]4Current NDC, Legacy NDC, 4 package rows20240223_9c7d65e4-df2f-47c1-a185-66aaf19aad2b.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 32 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Low Dose AspiriunASPIRINAMERIFOODS TRADING COMPANY3802c96a-5e2a-ba9c-e063-6394a90abb782025-11-20WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENHYVEE INC4227aeb1-dd2c-9ca1-e063-6294a90ad7092025-11-20WarningsExact identifier
application number: M013
good sense pain reliefACETAMINOPHENNuCare Pharamceuticals, Inc.440c13d7-edf0-f611-e063-6394a90af9952025-11-20WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENHYVEE INC4227a2cc-69fa-869d-e063-6294a90a1d412025-11-20WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENHYVEE INC422796ed-7558-f7e8-e063-6294a90ad1c72025-11-20WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENHYVEE INC3e61abe4-b4be-01af-e063-6394a90a8b242025-11-20WarningsExact identifier
application number: M013
Pain Relief PMACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEHYVEE INC3e60703b-a5cf-333a-e063-6394a90a20872025-11-20WarningsExact identifier
application number: M013
ASPIRINASPIRINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED54e4ae54-caf8-4105-8428-256f56a2f68f2025-11-19WarningsExact identifier
application number: M013
MIDOL COMPLETEACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATER J General Corporation0c09a178-1a07-4079-b4a6-d1657cb8e7142025-11-17WarningsExact identifier
application number: M013
Alka-Seltzer OriginalANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATER J General Corporationdbb0d067-71f0-45e4-bc98-548cf4a90b3a2025-11-17WarningsExact identifier
application number: M013
MOTRIN IBIBUPROFENR J General Corporationafa87bb5-7fcb-4ccd-acac-f7931242181f2025-11-17WarningsExact identifier
application number: M013
TYLENOL EXTRA STRENGTHACETAMINOPHENR J General Corporation99e45e83-37a3-44df-9a2a-98ba7457a5bb2025-11-17WarningsExact identifier
application number: M013
TYLENOL PM EXTRA STRENGTHACETAMINOPHENR J General Corporationa40ea0e3-d666-4605-b5e0-beeaf8f586f22025-11-17WarningsExact identifier
application number: M013
Acetaminophen 250 mg and Ibuprofen 125 mgACETAMINOPHEN 250 MG AND IBUPROFEN 125 MGR J General Corporation68d3be55-9340-4cc9-a05a-12b9338ddc562025-11-17WarningsExact identifier
application number: M013
Ibuprofen 200 mgIBUPROFENR J General Corporationdd9aaf80-6c2b-41a3-87b9-61642aaed4f02025-11-17WarningsExact identifier
application number: M013
Ibuprofen 200 mgIBUPROFENR J General Corporation1c18a2da-1718-4c00-aea8-9fb4a34183122025-11-17WarningsExact identifier
application number: M013
Ibuprofen 200 mgIBUPROFENR J General Corporationcd3060a5-3b90-42e4-89cd-3b620859045f2025-11-17WarningsExact identifier
application number: M013
Ibuprofen 200 mgIBUPROFENR J General Corporation1c7221ae-52d1-4d18-b586-c47ff656150d2025-11-17WarningsExact identifier
application number: M013
Excedrin Extra Strength HeadacheACETAMINOPHEN, ASPIRIN (NSAID), CAFFEINER J General Corporation907c89e7-2482-465f-9f85-2381ecab1b862025-11-17WarningsExact identifier
application number: M013
Bayer Genuine AspirinASPIRINR J General Corporation23daa359-d40f-4f64-81be-6d154f41df9f2025-11-17WarningsExact identifier
application number: M013

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-990-0071205099000100 TABLET in 1 BOTTLE, PLASTIC (71205-990-00) 100 tablet2020-04-010000-00-00NoNoCurrent
71205-990-11712050990111000 TABLET in 1 BOTTLE, PLASTIC (71205-990-11) 1000 tablet2020-04-010000-00-00NoNoCurrent
71205-990-507120509905050 TABLET in 1 BOTTLE, PLASTIC (71205-990-50) 50 tablet2020-04-010000-00-00NoNoCurrent
71205-990-5571205099055500 TABLET in 1 BOTTLE, PLASTIC (71205-990-55) 500 tablet2020-04-010000-00-00NoNoCurrent