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 3 of 106 · 2,108 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EELHOE Body Coverage PerfectorTITANIUM DIOXIDEShantou Eelhoe Daily Chemical Technology Co., Ltd.5610c3b7-456b-3bc1-e063-6394a90a3fa82026-07-07WarningsExact identifier
unii: 15FIX9V2JP
Premier Tinted Mineral SunscreenBROAD SPECTRUM SPF30Emerald Aesthetics LLC55f88dd1-346c-22a5-e063-6294a90a711f2026-07-06WarningsExact identifier
unii: 15FIX9V2JP
OHUI Ultimate Cover CC Cushion Compact 02 Natural BeigeTITANIUM DIOXIDELG H&H Co., Ltd.d307471c-6cc6-ce48-e053-2995a90a3e022026-07-02WarningsExact identifier
unii: 15FIX9V2JP
Evereden Fluid Silk Mineral Sunscreen PRO SPF50TITANIUM DIOXIDE, ZINC OXIDEEden Brands Inc.2cb7773f-9a05-ad02-e063-6294a90af0242026-07-01WarningsExact identifier
unii: 15FIX9V2JP
OHUI Ultimate Cover CC Cushion Compact 01 Light BeigeTITANIUM DIOXIDELG H&H Co., Ltd.d2f9c54b-ac4e-5141-e053-2a95a90aa2b82026-06-30WarningsExact identifier
unii: 15FIX9V2JP
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYTarget Corporation36602b7a-99c0-f6a4-e063-6294a90a87582026-06-29WarningsExact identifier
unii: 1K09F3G675
TOCOBO Blur Finish Sun Cushion Cotton BlueHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEPICTON Co., Ltd.4d6ddee3-9a76-6c9c-e063-6394a90a15292026-06-29WarningsExact identifier
unii: 15FIX9V2JP
Earth Baby Broad Spectrum SPF 30SUNSCREENEarth Baby, Inc.42556876-74ea-38e6-e054-00144ff8d46c2026-06-28WarningsExact identifier
unii: 15FIX9V2JP
Sun Does Matter Daily Face SunscreenHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDESundoesmatter Company Inc.553687d8-d4e1-8361-e063-6294a90a24fe2026-06-27WarningsExact identifier
unii: 15FIX9V2JP
Ivory Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc552f25ba-61d5-6a94-e063-6394a90a46e92026-06-26WarningsExact identifier
unii: 15FIX9V2JP
Simply Beige Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc552f4799-9122-8db5-e063-6394a90a51322026-06-26WarningsExact identifier
unii: 15FIX9V2JP
Vanilla Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc552f6d2c-9b8c-aa52-e063-6294a90a787e2026-06-26WarningsExact identifier
unii: 15FIX9V2JP
Coral Isle SPF 50 Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDERocky Mountain5515f562-62d9-c6ee-e063-6294a90a9ea62026-06-25WarningsExact identifier
unii: 15FIX9V2JP
Delicate Beige Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc551928b4-74bb-3f6c-e063-6294a90a6b832026-06-25WarningsExact identifier
unii: 15FIX9V2JP
Alabaster Beige Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc5519290c-b040-6a37-e063-6394a90a8a1d2026-06-25WarningsExact identifier
unii: 15FIX9V2JP
Soft Bisque Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc551ab7d1-dd2f-c6d8-e063-6394a90aff652026-06-25WarningsExact identifier
unii: 15FIX9V2JP
Alabaster Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc551b8c21-3afc-c804-e063-6294a90a51562026-06-25WarningsExact identifier
unii: 15FIX9V2JP
Bare Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc552f20b2-9a2e-70f3-e063-6394a90a93372026-06-25WarningsExact identifier
unii: 15FIX9V2JP
CalaSootheCALAMINE, MENTHOL, AND ZINC OXIDEDynarex Corporation54f12005-acfe-4821-e063-6394a90ac3042026-06-24WarningsExact identifier
unii: 1K09F3G675
BROAD SPECTRUM SPF 50 UNIVERSAL TINTED SUNSCREENTITANIUM DIOXIDEShantou Woodsleep Biotechnology Co., Ltd.54fc80b7-8f6c-e2be-e063-6394a90a4b592026-06-24WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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