FDA.reportPublic FDA data

NDC 0597-0122-27 - Zantac 75

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
0597-0122
Requested NDC
0597-0122-27
Package NDCs from labels
0597-0122-34, 0597-0122-54, 0597-0122-81, 0597-0122-40, 0597-0122-61, 0597-0122-96, 0597-0122-08, 0597-0122-01, 0597-0122-37, 0597-0122-13, 0597-0122-27
Manufacturer
Navajo Manufacturing Company Inc.
Effective date
2019-11-21
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Zantac 75Navajo Manufacturing Company Inc.2019-11-21HUMAN OTC DRUG LABEL
Zantac 75 ® Drug FactsBoehringer Ingelheim Pharmaceuticals Inc. | Patheon Manufacturing Services LLC | Boehringer Ingelheim Promeco S.A de C.V.2019-11-20HUMAN OTC DRUG LABEL
Zantac 75 ® Drug FactsCentral Texas Community Health Centers | Travis County Healthcare District2018-04-26HUMAN OTC DRUG LABEL
Zantac 75 - Carilion Materials ManagementCarilion Materials Management2017-12-28HUMAN OTC DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0597-0122-13EA - Each0597-01225a13a602-c54e-42c4-9cef-24838673b0bf12019-01-24
0597-0122-27EA - Each0597-0122afb7291f-7243-4c18-bdee-e0879aa0c61612012-07-24
0597-0122-37EA - Each0597-0122ee19f11b-ad30-42d0-891e-1107a171b39012012-07-24
0597-0122-54EA - Each0597-0122ed679226-297f-44f2-bdb7-4858939d94af12012-07-24
0597-0122-81EA - Each0597-01223cff1c2d-45e2-42a7-9fba-d96088f38dcb12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ranitidine hydrochlorideACTIVE INGREDIENTBK76465IHMZANTAC 75 (RANITIDINE) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS INC.]6
ranitidineACTIVE MOIETY884KT10YB7ZANTAC 75 (RANITIDINE) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS INC.]6
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UZANTAC 75 (RANITIDINE) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS INC.]6
ferric oxide redINACTIVE INGREDIENT1K09F3G675ZANTAC 75 (RANITIDINE) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS INC.]6
hypromellosesINACTIVE INGREDIENT3NXW29V3WOZANTAC 75 (RANITIDINE) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS INC.]6
magnesium stearateINACTIVE INGREDIENT70097M6I30ZANTAC 75 (RANITIDINE) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS INC.]6
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPZANTAC 75 (RANITIDINE) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS INC.]6
triacetinINACTIVE INGREDIENTXHX3C3X673ZANTAC 75 (RANITIDINE) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS INC.]6
ranitidine hydrochlorideACTIVE INGREDIENTBK76465IHMZANTAC 75 (RANITIDINE) TABLET, COATED [CARILION MATERIALS MANAGEMENT]2
ranitidineACTIVE MOIETY884KT10YB7ZANTAC 75 (RANITIDINE) TABLET, COATED [CARILION MATERIALS MANAGEMENT]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UZANTAC 75 (RANITIDINE) TABLET, COATED [CARILION MATERIALS MANAGEMENT]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ZANTAC 75 (RANITIDINE) TABLET, COATED [CARILION MATERIALS MANAGEMENT]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOZANTAC 75 (RANITIDINE) TABLET, COATED [CARILION MATERIALS MANAGEMENT]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ZANTAC 75 (RANITIDINE) TABLET, COATED [CARILION MATERIALS MANAGEMENT]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPZANTAC 75 (RANITIDINE) TABLET, COATED [CARILION MATERIALS MANAGEMENT]2
TRIACETININACTIVE INGREDIENTXHX3C3X673ZANTAC 75 (RANITIDINE) TABLET, COATED [CARILION MATERIALS MANAGEMENT]2

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 1 of 107 · 2,122 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
CalamineCALAMINE, PRAMOXINE HCLUnited Natural Foods, Inc. dba UNFI0bc1a9b4-1210-4d9a-bbd2-40e9225e86ea2026-09-04Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
CalamineFERRIC OXIDE REDYour Military Exchangesaf95a66c-f063-4019-80c6-6f7dc4fee4d82026-08-28Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.5a0b4bd2-f6ad-35dc-e063-6294a90a8a662026-08-27WarningsExact identifier
unii: 15FIX9V2JP
MELAO Hydrating Lightweight SunscreenAVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd59eeaea1-d726-99f3-e063-6394a90aeea32026-08-26WarningsExact identifier
unii: 15FIX9V2JP
Calamine PlusCALAMINE, PRAMOXINE HYDROCHLORIDEKroger Company44fdd5a4-3cac-15e5-e063-6294a90adb522026-08-26WarningsExact identifier
unii: 1K09F3G675
Q Skin ScienceSUNSCREENInternational Cosmeceuticals, Inc59e4c3d0-ee4c-2350-e063-6394a90ac9d22026-08-25WarningsExact identifier
unii: 15FIX9V2JP
MELAO zinc stick(GREEN)TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENEGuangzhou Haishi Biological Technology Co., Ltd.59c70c82-f7ff-9a04-e063-6294a90a7b3d2026-08-24WarningsExact identifier
unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25/ Mineral sunscreen broad Spectrum SPF 25 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.59d74e3f-e3fa-a7a9-e063-6294a90a76e52026-08-24WarningsExact identifier
unii: 15FIX9V2JP
Rohto All-In-OneHYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATEThe Mentholatum Company43e690e4-b381-46e3-838c-33aef5bdadde2026-08-20WarningsExact identifier
unii: 3NXW29V3WO
Sweat Resistant Sunscreen Body OriginalTITANIUM DIOXIDE, ZINC OXIDEClutch, Inc.4bbde755-e312-123e-e063-6294a90a467f2026-08-20WarningsExact identifier
unii: 15FIX9V2JP
HEADHUNTER SURF SCREEN SPF 50 SUNSCREENZINC OXIDE,TITANIUM DIOXIDEGuangzhou Tata Biotechnology Co., Ltd.4339df13-77d3-31a1-e063-6394a90a52082026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30HAMBLIN DERMATOLOGY5942e64c-416e-7525-e063-6394a90a28392026-08-17WarningsExact identifier
unii: 15FIX9V2JP
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
Leader Dry Eye Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400CARDINAL HEALTH 110, LLC. DBA LEADER2ded4bda-b3c3-4521-8701-5c8446fd148b2026-08-17WarningsExact identifier
unii: 3NXW29V3WO
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30DR. SAMRAO'S OFFICE58b2ca35-11ed-d848-e063-6294a90a5b372026-08-11WarningsExact identifier
unii: 15FIX9V2JP
Dr. Shitong Photon Energy Eye Care LiquidTETRAHYDROZOLINE HCL 0.05% HYPROMELLOSE 0.3% DR. SHITONG PHOTON ENERGY EYE CARE LIQUIDWenzhou Yuyuan Pharmaceutical Co., Ltd.58ace434-55ef-17ef-e063-6294a90aa8782026-08-10WarningsExact identifier
unii: 3NXW29V3WO
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

Reported adverse events (FAERS/openFDA)#

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