NDC 0378-0317-05 - Cimetidine

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
0378-0317
Requested NDC
0378-0317-05
Package NDCs from labels
0378-0317-01, 0378-0317-05
Manufacturer
Mylan Pharmaceuticals Inc.
Effective date
2026-07-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Cimetidine - Mylan Pharmaceuticals Inc.Mylan Pharmaceuticals Inc.2026-07-15HUMAN PRESCRIPTION DRUG LABEL
CIMETIDINE - STAT RX USA LLCSTAT RX USA LLC2011-01-28HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0378-0317-01Cimetidine100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-0317CIMETIDINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]11Current NDC, Legacy NDC, 1 package rows20240113_06c0a509-026f-44e0-9975-a94a8de51d43.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-0317-01EA - Each0378-0317b9f3719d-5366-48f1-a0b6-f84e6eaa0dfa12012-07-24
0378-0317-05EA - Each0378-0317691550bb-24f1-4d70-bb95-2805943d2ca812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CIMETIDINEACTIVE INGREDIENT80061L1WGDCIMETIDINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]6
CIMETIDINEACTIVE MOIETY80061L1WGDCIMETIDINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCIMETIDINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]6
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CIMETIDINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]6
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCIMETIDINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]6
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCIMETIDINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]6
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCIMETIDINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]6
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CIMETIDINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]6
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCIMETIDINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]6
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62CIMETIDINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CIMETIDINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]6
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IECIMETIDINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]6
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACIMETIDINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]6
POVIDONESINACTIVE INGREDIENTFZ989GH94ECIMETIDINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]6
SODIUM ALGINATEINACTIVE INGREDIENTC269C4G2ZQCIMETIDINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]6
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCIMETIDINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]6
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCIMETIDINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCIMETIDINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]6
TRIACETININACTIVE INGREDIENTXHX3C3X673CIMETIDINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]6
VANILLININACTIVE INGREDIENTCHI530446XCIMETIDINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]6
CIMETIDINEACTIVE INGREDIENT80061L1WGDCIMETIDINE TABLET, FILM COATED [STAT RX USA LLC]1
CIMETIDINEACTIVE MOIETY80061L1WGDCIMETIDINE TABLET, FILM COATED [STAT RX USA LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCIMETIDINE TABLET, FILM COATED [STAT RX USA LLC]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CIMETIDINE TABLET, FILM COATED [STAT RX USA LLC]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCIMETIDINE TABLET, FILM COATED [STAT RX USA LLC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCIMETIDINE TABLET, FILM COATED [STAT RX USA LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CIMETIDINE TABLET, FILM COATED [STAT RX USA LLC]1
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IECIMETIDINE TABLET, FILM COATED [STAT RX USA LLC]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ACIMETIDINE TABLET, FILM COATED [STAT RX USA LLC]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ECIMETIDINE TABLET, FILM COATED [STAT RX USA LLC]1
SODIUM ALGINATEINACTIVE INGREDIENTC269C4G2ZQCIMETIDINE TABLET, FILM COATED [STAT RX USA LLC]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCIMETIDINE TABLET, FILM COATED [STAT RX USA LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCIMETIDINE TABLET, FILM COATED [STAT RX USA LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCIMETIDINE TABLET, FILM COATED [STAT RX USA LLC]1
TRIACETININACTIVE INGREDIENTXHX3C3X673CIMETIDINE TABLET, FILM COATED [STAT RX USA LLC]1
VANILLININACTIVE INGREDIENTCHI530446XCIMETIDINE TABLET, FILM COATED [STAT RX USA LLC]1

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 108 · 2,145 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
Leader Artificial Tears 15 mLPOLYVINYL ALCOHOL, POVIDONECardinal Health8cccc589-3a8e-baad-e053-2a95a90ab8c72026-09-09WarningsExact identifier
unii: FZ989GH94E
FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPSPOVIDONE, POLYVINYL ALCOHOL SOLUTIONHarrow Eye, LLC049e9cc9-0663-53bc-e063-6294a90a2c4f2026-09-04WarningsExact identifier
unii: FZ989GH94E
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
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 Optic GlowNAPHAZOLINE HYDROCHLORIDE, POVIDONE, PROPYLENE GLYCOLThe Mentholatum Companydf9c5f7c-96e6-4b2b-b8cb-21a6a3342dff2026-08-20WarningsExact identifier
unii: FZ989GH94E
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
Rohto Preservative Free Dry AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Companyf4b1974c-2412-45f6-b79d-88b8a0bcb6082026-08-18WarningsExact identifier
unii: FZ989GH94E
Rohto Dry-AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Company8ea5c6c9-48f4-406a-a2cb-9280c546d87d2026-08-18WarningsExact identifier
unii: FZ989GH94E
Acid ReducerCIMETIDINEAmazon.com Services LLC81dbc581-aa51-46bf-8b69-6d926de2f5832026-08-18WarningsExact identifier
rxcui: 197505
unii: 80061L1WGD
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

Reported adverse events (FAERS/openFDA)#

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