FDA.reportPublic FDA data

NDC 17856-0353-2 - Pharbetol Regular strength

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
17856-0353
Requested NDC
17856-0353-2
Package NDCs from labels
17856-0353-2, 17856-0353-1, 17856-0353-4, 17856-0353-3
Manufacturer
ATLANTIC BIOLOGICALS CORP.
Effective date
2025-06-05
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
PHARBEST IBUPROFEN Drug FactsATLANTIC BIOLOGICALS CORP.2025-06-05HUMAN OTC DRUG LABEL
Pharbetol Regular strength - ATLANTIC BIOLOGICALS CORP. | UNIT DOSE SOLUTIONSATLANTIC BIOLOGICALS CORP. | UNIT DOSE SOLUTIONS2024-04-30HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17856-0353-12024-06-26C16284748780-11030e365-250f-111a-e063-dadaa90a10e2PHARBEST IBUPROFEN Drug Facts
17856-0353-12024-01-30C16284748780-11030e365-250f-111a-e063-dadaa90a10e2PHARBEST IBUPROFEN Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0353-1PharbetolRegular strength100 in 1 BOX, UNIT-DOSETABLET1003
17856-0353-2PharbetolRegular strength1 in 1 POUCHTABLET13
17856-0353-4PharbetolRegular strength24 in 1 BOTTLETABLET243
17856-0353-3PharbetolRegular strength28 in 1 BOTTLETABLET281

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0353PHARBETOL REGULAR STRENGTH (ACETAMINOPHEN) TABLET [ATLANTIC BIOLOGICALS CORP.]2Current NDC, Legacy NDC, 3 package rows20240627_05a91d24-b498-4ba2-a275-68b871cf62d2.zip
17856-0353PHARBETOL REGULAR STRENGTH (ACETAMINOPHEN) TABLET [ATLANTIC BIOLOGICALS CORP.]1Current NDC, Legacy NDC, 1 package rows20240508_bd26081c-e81e-42e8-b3da-2813863a51df.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 64 of 182 · 3,623 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDELil' Drug Store Products, Inc.5b493ed7-9044-4841-9935-236d0bdc71a92025-12-23WarningsExact identifier
unii: 362O9ITL9D
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDELil' Drug Store Products, Inc.77a7ff9a-a414-4053-8d8d-369907d4380d2025-12-23WarningsExact identifier
unii: 362O9ITL9D
Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATELil' Drug Store Products, Inc.8f320235-f243-4211-b99c-18526e6865482025-12-23WarningsExact identifier
unii: 362O9ITL9D
Circle K Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDELil' Drug Store Products, Inc.b6a46498-d9a8-4da2-9283-57d135f305a52025-12-23WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENCVS PHARMACY INCbd8ce39f-ccf8-3976-e053-2a95a90abb1f2025-12-23WarningsExact identifier
unii: 362O9ITL9D
Circle K Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATELil' Drug Store Products, Inc.7c5faec2-28c6-4c15-a268-d8b578140b742025-12-23WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENPUBLIX SUPERMARKETS, INC08f5af1d-365b-a97c-e063-6394a90a99ae2025-12-23WarningsExact identifier
application number: M013
unii: 362O9ITL9D
ACETAMINOPHEN 500 MGACETAMINOPHENPioneer Life Sciences, LLC0d67bb52-7ae3-439e-9e47-4e21eb0ca3522025-12-23WarningsExact identifier
application number: M013
unii: 362O9ITL9D
Hand Sanitizer Solution 101BENZALKONIUM CHLORIDEMorgan Gallacher Inc. DBA Custom Chemical Formulators Inc.81fa10d3-6dbb-4a72-bfff-2dd795f949682025-12-23WarningsExact identifier
application number: M
MG DermaWashBENZALKONIUM CHLORIDEMorgan Gallacher Inc. DBA Custom Chemical Formulators Inc.0bb37363-418f-46c7-8c39-9ef9aa5023f72025-12-23WarningsExact identifier
application number: M
Members Mark Arthritis PainACETAMINOPHENSam's West Inc4cbe2880-fea9-4d7b-9e7f-a0c794864a842025-12-23WarningsExact identifier
unii: 362O9ITL9D
MG DermaGel 62 LVETHYL ALCOHOLMorgan Gallacher Inc. DBA Custom Chemical Formulators Inc.437a508d-31ba-49b4-b821-4bf57b596e332025-12-23WarningsExact identifier
application number: M
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENCranbury Pharmaceuticals, LLCd8fe4ae4-bd19-42eb-b74d-f302b3f914ee2025-12-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Antibacterial Liquid HandBENZALKONIUM CHLORIDEMorgan Gallacher Inc. DBA Custom Chemical Formulators Inc.ea0a5970-e95f-4090-bbe3-7df9e04393b52025-12-23WarningsExact identifier
application number: M
ACETAMINOPHEN 500 MGACETAMINOPHENPioneer Life Sciences, LLC11e6ec2a-5171-4496-a15f-6ff744bd1f2f2025-12-23WarningsExact identifier
application number: M013
unii: 362O9ITL9D
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENAurolife Pharma, LLC69df20d9-b1d5-47dc-9ff0-29987284f8c72025-12-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENCranbury Pharmaceuticals, LLCd4caec6d-4af2-4f1c-9add-c0c948b83b162025-12-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATEAurolife Pharma, LLC02386806-02d4-47e3-9c8b-7810146ee7952025-12-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
MG DermaCleanN/AMorgan Gallacher Inc.ed3d983e-0a6e-4de4-832a-0020f77110112025-12-23WarningsExact identifier
application number: M
Safetussin High Blood Pressure and diabetes Cough, Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESINKRAMER LABORATORIES279e309c-040d-4001-808d-b7d986a9a1d82025-12-23WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.