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 12 of 183 · 3,650 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NIGHTTIME SEVERE COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDd1115a55-35cd-4f20-8872-f42983a5ebcd2026-07-28WarningsExact identifier
unii: 362O9ITL9D
Childrens Pain and FeverACETAMINOPHENAurohealth LLCf818996c-36d2-4d3d-af3e-39949157edb92026-07-28WarningsExact identifier
application number: M013
unii: 362O9ITL9D
Pain Reliever PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLL.N.K. International, Inc.03b871e8-3e14-4ed8-a978-45129255b2722026-07-27WarningsExact identifier
application number: M013
unii: 362O9ITL9D
OXYCODONE AND ACETAMINOPHENOXYCODONE HYDROCHLORIDE AND ACETAMINOPHENSpecGx LLCf2137f1a-b49a-40bd-97ac-cd6b36e295f42026-07-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Cold and Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, TRIPROLIDINE HCLWalgreen Company0a48f650-ad2a-4105-9ff4-2bc4d94b46d32026-07-27WarningsExact identifier
unii: 362O9ITL9D
Pain Relief Acetaminophen PM Extra StrengthACETAMINOPHEN AND DIPHENHYDRAMINE HCLRite Aid Corporation17d27771-a112-474f-9a58-29af0d7e1af32026-07-27WarningsExact identifier
application number: M013
unii: 362O9ITL9D
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Company84202ebe-97b6-4be2-bb09-7f2729303f962026-07-27WarningsExact identifier
unii: 362O9ITL9D
Daytime Severe Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLRite Aid Corporation8d41defe-8120-4cbb-b42e-c805cc5a794b2026-07-24WarningsExact identifier
unii: 362O9ITL9D
Infants TYLENOLACETAMINOPHENKenvue Brands LLC2143cc16-86db-4060-96da-5c228ae9207b2026-07-24WarningsExact identifier
application number: M013
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENSoftgel Healthcare Pvt Ltd352bb451-ffdc-411a-e063-6294a90a8cf52026-07-24WarningsExact identifier
application number: M013
unii: 362O9ITL9D
Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine HydrochlorideACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDEProdose, Inc.3afc88c7-388a-dbd9-e063-6294a90a4faf2026-07-24WarningsExact identifier
unii: 362O9ITL9D
Feverall InfantsACETAMINOPHENSun Pharmaceutical Industries, Inc.3ade895b-5dca-4d81-9415-8091923162ff2026-07-24WarningsExact identifier
unii: 362O9ITL9D
acetaminophenACETAMINOPHENNuCare Pharmaceuticals,Inc.fdb7331a-d029-8b2a-e053-6294a90adfcd2026-07-24WarningsExact identifier
application number: M013
unii: 362O9ITL9D
Childrens Pain and FeverACETAMINOPHENAurohealth LLC5ada044e-50e8-4874-ac04-df5f1f9e735d2026-07-24WarningsExact identifier
application number: M013
unii: 362O9ITL9D
childrens fever reducer and pain relieverACETAMINOPHENRite Aid Corporationa63727c3-64d8-4ae9-8da3-974cae6beed22026-07-24WarningsExact identifier
application number: M013
unii: 362O9ITL9D
Childrens Pain and FeverACETAMINOPHENAurohealth LLCe4a2566e-48ec-4602-87e3-143398d15f332026-07-24WarningsExact identifier
application number: M013
unii: 362O9ITL9D
infants fever reducer and pain relieverACETAMINOPHENRite Aid Corporation920e7055-7ed1-4db4-9215-f8933078bb7b2026-07-24WarningsExact identifier
application number: M013
unii: 362O9ITL9D
Dye Free Pain and Fever ChildrensACETAMINOPHENWalgreensc6665c11-9a01-4472-a444-acadb1de0b692026-07-23WarningsExact identifier
application number: M013
unii: 362O9ITL9D
COLDTAC PlusACETAMINOPHEN, PHENYLEPHRIN HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDEOPMX LLC3496866c-682f-420b-bfdb-64ecebbf70a22026-07-23WarningsExact identifier
unii: 362O9ITL9D
Cold and Flu NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED0ab2ba6a-1fac-4a34-ab76-0b50b425d0ba2026-07-22WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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