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 35 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Goodys Cool Orange HeadacheACETAMINOPHEN AND ASPIRIN AND CAFFEINEMedtech Products Inc.31212c97-9975-427e-bc3d-f7125f30299a2025-10-23WarningsExact identifier
application number: M013
BC ArthritisASPIRIN AND CAFFEINEMedtech Products Inc.3a85be2d-6548-4de5-8109-60e1ca2bfca32025-10-23WarningsExact identifier
application number: M013
Goodys Extra StrengthACETAMINOPHEN, ASPIRIN, AND CAFFEINEMedtech Products Inc.d4325b17-23bc-44ac-868d-bb0886853a732025-10-23WarningsExact identifier
application number: M013
BCASPIRIN AND CAFFEINEMedtech Products Inc.226173d4-b6d5-4fe6-b24e-1cc5d1b31c882025-10-23WarningsExact identifier
application number: M013
BC MAXASPIRIN, ACETAMINOPHEN, CAFFEINEMedtech Products Inc.1e2a07ab-23e6-49b4-a676-212dc6880f142025-10-23WarningsExact identifier
application number: M013
Ecotrin Regular StrengthASPIRINMedtech Products Inc.36cb530b-25b2-4f62-a25d-aa04360815a82025-10-23WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENTOPCO ASSOCIATES LLCbbc367cc-6c79-498e-8fca-1347e6ea1a8c2025-10-22WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENRugby Laboratoriesb16ed4ef-689c-4df2-ab6c-207aa8b9925d2025-10-22WarningsExact identifier
application number: M013
Tension Headache ReliefACETAMINOPHEN, CAFFEINETIME CAP LABS INC05364eb4-07a1-a4d9-e063-6294a90a47e52025-10-21WarningsExact identifier
application number: M013
Acetaminophen, Aspirin, CaffeineACETAMINOPHEN, ASPIRIN, CAFFEINECVS Pharmacy, Inc.6deb854f-863e-24ad-e053-2991aa0afb172025-10-21WarningsExact identifier
application number: M013
BackAidACETAMINOPHEN, CAFFEINEKobayashi Healthcare International, Inc.25db6bb5-96b6-4be1-e063-6294a90a23002025-10-21WarningsExact identifier
application number: M013
M-PAPACETAMINOPHENMethod Pharmaceuticals, LLC1539dc44-15a0-153b-e063-6294a90a9d452025-10-21WarningsExact identifier
application number: M013
M-PAPACETAMINOPHENMethod Pharmaceuticals, LLC3d1bb61c-15db-4eba-aba9-cfbcbc7b30e02025-10-21WarningsExact identifier
application number: M013
Walgreens Antacid Pain Relief Extra StrengthASPIRIN, CITRIC ACID, SODIUM BICARBONATEWalgreensb60df498-07db-500b-e053-2a95a90aff6a2025-10-17WarningsExact identifier
application number: M013
Equate Effervescent Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEWalmart6271b34b-55a0-40a8-e053-2a91aa0acb222025-10-17Warnings, Adverse reactionsExact identifier
application number: M013
Xesso NeoBENZOCAINEPREMIUM NATURAL COSMETICS INC163f32cd-4e51-950a-e063-6394a90a48162025-10-17WarningsExact identifier
application number: M013
Menstrual Complete Maximum StrengthACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATECHAIN DRUG MARKETING ASSOCIATION INC913d8bdb-7644-464c-b9a6-55387ff120592025-10-17WarningsExact identifier
application number: M013
Alka-Seltzer Hangover ReliefANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATEBayer HealthCare LLC.dc235b06-999e-221d-e053-2a95a90a0ce12025-10-16WarningsExact identifier
application number: M013
Aspirin 81mgASPIRIN ENTERIC COATED TABLETS 81MGVITANE PHARMACEUTICALS, INC41386de5-5857-efab-e063-6294a90afd9c2025-10-15WarningsExact identifier
application number: M013
Aspirin 81mgASPIRIN ENTERIC COATED TABLETS 81MGVITANE PHARMACEUTICALS, INC4138d4c0-baa5-1f20-e063-6394a90a788f2025-10-15WarningsExact 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