FDA.reportPublic FDA data

NDC 58602-705-03 - Famotidine

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
58602-705
Requested NDC
58602-705-03
Package NDCs from labels
58602-705-15, 58602-705-19, 58602-705-84, 58602-705-03, 58602-705-09, 58602-705-12, 58602-705-93, 58602-705-14, 58602-705-34, 58602-705-39, 58602-705-44, 58602-705-40, 58602-705-88, 58602-705-41, 58602-705-32
Manufacturer
Aurohealth LLC | Aurobindo Pharma Limited | APL HEALTHCARE LIMITED
Effective date
2025-03-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Famotidine - Aurohealth LLC | Aurobindo Pharma Limited | APL HEALTHCARE LIMITEDAurohealth LLC | Aurobindo Pharma Limited | APL HEALTHCARE LIMITED2025-03-15Human OTC Drug Label
Famotidine - Proficient Rx LPProficient Rx LP2022-06-01HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58602-705-03Famotidine10 in 1 BLISTER PACKTABLET, FILM COATED1013
58602-705-09Famotidine3 in 1 CARTONTABLET, FILM COATED313
58602-705-12Famotidine4 in 1 CARTONTABLET, FILM COATED413
58602-705-14Famotidine1 in 1 CARTONTABLET, FILM COATED113
58602-705-14Famotidine50 in 1 BOTTLETABLET, FILM COATED5013
58602-705-15Famotidine1 in 1 CARTONTABLET, FILM COATED113
58602-705-15Famotidine60 in 1 BOTTLETABLET, FILM COATED6013
58602-705-19Famotidine1 in 1 CARTONTABLET, FILM COATED113
58602-705-19Famotidine90 in 1 BOTTLETABLET, FILM COATED9013
58602-705-32Famotidine180 in 1 BOTTLETABLET, FILM COATED18013
58602-705-32Famotidine1 in 1 CARTONTABLET, FILM COATED113
58602-705-34Famotidine1 in 1 CARTONTABLET, FILM COATED113
58602-705-34Famotidine200 in 1 BOTTLETABLET, FILM COATED20013
58602-705-39Famotidine1 in 1 CARTONTABLET, FILM COATED113
58602-705-39Famotidine365 in 1 BOTTLETABLET, FILM COATED36513
58602-705-40Famotidine500 in 1 BOTTLETABLET, FILM COATED50013
58602-705-40Famotidine1 in 1 CARTONTABLET, FILM COATED113
58602-705-41Famotidine1000 in 1 BOTTLETABLET, FILM COATED100013
58602-705-41Famotidine1 in 1 CARTONTABLET, FILM COATED113
58602-705-44Famotidine1 in 1 CARTONTABLET, FILM COATED113
58602-705-44Famotidine400 in 1 BOTTLETABLET, FILM COATED40013
58602-705-84Famotidine1 in 1 CARTONTABLET, FILM COATED113
58602-705-84Famotidine30 in 1 BOTTLETABLET, FILM COATED3013
58602-705-88Famotidine750 in 1 BOTTLETABLET, FILM COATED75013
58602-705-88Famotidine1 in 1 CARTONTABLET, FILM COATED113
58602-705-93Famotidine90 in 1 BOTTLETABLET, FILM COATED9013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58602-705FAMOTIDINE TABLET, FILM COATED [AUROHEALTH LLC]13Current NDC, Legacy NDC, 26 package rows20250321_756c7234-6a63-4b1b-be36-2b1ed09e67a0.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58602-705-15EA - Each58602-705f2623aa0-791a-40af-ac34-8254bc52f7c912022-02-07
58602-705-19EA - Each58602-7056402435b-39ad-40bf-aadd-6feba559e09812021-04-08
58602-705-84EA - Each58602-70571d62bb7-0854-4a7b-9efa-f26c2d6522d612020-07-13

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 2 of 122 · 2,434 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Protect Tinted Mineral SunscreenBROAD SPECTRUM SPF30Opal Day Spa5943413a-48e1-0bdf-e063-6294a90a2fff2026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30MedSpa By Beauty Bar LLC5943ba3d-688e-9e9c-e063-6294a90afa9a2026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30CORBY, JR., TERRY L.594443fd-8e27-4ec6-e063-6294a90a3ff02026-08-17WarningsExact identifier
unii: 15FIX9V2JP
FamotidineFAMOTIDINEPreferred Pharmaceuticals Inc.cd95271c-cf39-47fb-97a6-f6ee1e619e4a2026-08-12Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30DR. SAMRAO'S OFFICE58b2ca35-11ed-d848-e063-6294a90a5b372026-08-11WarningsExact identifier
unii: 15FIX9V2JP
heartburn preventionFAMOTIDINEKroger Companyc97851ef-7b49-4f6c-b165-147555db101a2026-08-11WarningsExact identifier
unii: 5QZO15J2Z8
Journee Firm Riche Broad Spectrum Sunscreen SPF 30TITANIUM DIOXIDE AND ZINC OXIDEMerz North America, Inc.d4d4bfcf-3674-4847-8ad8-1716a8e821ae2026-08-10WarningsExact identifier
unii: 15FIX9V2JP
VEIRFOO Brightening Hydrating Antiwrinkle SunscreenTITANIUM DIOXIDE, OCTINOXATELCM TECHNOLOGY Co., Ltd4cbbf8aa-8910-b7e7-e063-6294a90a4f072026-08-07WarningsExact identifier
unii: 15FIX9V2JP
CalamineFERRIC OXIDE REDThe Kroger Co.9ddcd6ba-1aed-48f8-a91a-54bd6f0d93082026-08-06Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
EltaMD UV RestoreTITANIUM DIOXIDE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc37fee381-ce6b-4949-9a4a-778aa839fb842026-08-06WarningsExact identifier
unii: 15FIX9V2JP
ACID REDUCERFAMOTIDINECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDf347f870-1da4-4a77-8c20-63b703d240712026-08-05WarningsExact identifier
unii: 5QZO15J2Z8
Luxe Gloss Hydrating Lip Gloss SPF 35-NAKED HONEYOCTOCRYLENE 8%, OCTISALATE 5%, TITANIUM DIOXIDE 6%, ZINC OXIDE 8%Lale Cosmetics LLC581fb0cd-c55d-d562-e063-6394a90a7f112026-08-03WarningsExact identifier
unii: 15FIX9V2JP
EltaMD UV ActiveZINC OXIDE AND TITANIUM DIOXIDE SUNSCREENCP Skin Health Group, Inc39d16479-d491-4c19-aa11-674461687c7b2026-08-03WarningsExact identifier
unii: 15FIX9V2JP
Ibuprofen and famotidineIBUPROFEN AND FAMOTIDINEDoc Rx9f5de6af-e555-4efd-a3ed-b72c34c051b62026-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8
Continuous Correction CreamTITANIUM DIOXIDEBaxter of California, LLC1cbcc648-f2e1-af60-e063-6294a90ad4bb2026-07-31WarningsExact identifier
unii: 15FIX9V2JP
Cover CremeTITANIUM DIOXIDEBaxter of California31f5e8c4-523f-4596-e063-6294a90a6a122026-07-31WarningsExact identifier
unii: 15FIX9V2JP
FAMOTIDINEFAMOTIDINEPD-Rx Pharmaceuticals, Inc.a0f38398-4d34-4ecc-8a6a-37732adaaad32026-07-30Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8
Ibuprofen and famotidineIBUPROFEN AND FAMOTIDINEAscend Laboratories, LLC4493d4cd-ca8e-4b0a-9b65-b75e55bf8b9e2026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8
DUAL ACTION COMPLETEFAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDEAmazon.com Services LLC4e8a936c-b876-4923-ad9e-d23537b5d7cf2026-07-28WarningsExact identifier
unii: 5QZO15J2Z8
FamotidineFAMOTIDINEAscend Laboratories, LLCb2228be0-472b-4e47-9910-af0bf12fde772026-07-27Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8

Reported adverse events (FAERS/openFDA)#

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