FDA.reportPublic FDA data

NDC 51079-119-01 - Dicyclomine Hydrochloride

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
51079-119
Requested NDC
51079-119-01
Package NDCs from labels
51079-119-01, 51079-119-20
Manufacturer
Mylan Institutional Inc.
Effective date
2020-02-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Dicyclomine Hydrochloride - Mylan Institutional Inc.Mylan Institutional Inc.2020-02-07HUMAN PRESCRIPTION DRUG LABEL
Dicyclomine Hydrochloride - Cardinal HealthCardinal Health2018-09-25HUMAN PRESCRIPTION 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
51079-119-01EA - Each51079-11967cf0d0e-f2f3-4e9a-8c75-d61fafff18c312012-07-24
51079-119-20EA - Each51079-119f439cb31-c73e-49c9-b2eb-59779234954b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DICYCLOMINE HYDROCHLORIDEACTIVE INGREDIENTCQ903KQA31DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]8
DICYCLOMINEACTIVE MOIETY4KV4X8IF6VDICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]8
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKDICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]8
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]8
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]8
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]8
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]8
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]8
GELATININACTIVE INGREDIENT2G86QN327LDICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]8
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]8
SHELLACINACTIVE INGREDIENT46N107B71ODICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]8
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]8
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]8
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [CARDINAL HEALTH]8
DICYCLOMINE HYDROCHLORIDEACTIVE INGREDIENTCQ903KQA31DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]3
DICYCLOMINEACTIVE MOIETY4KV4X8IF6VDICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]3
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKDICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]3
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]3
GELATININACTIVE INGREDIENT2G86QN327LDICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]3
SHELLACINACTIVE INGREDIENT46N107B71ODICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]3

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 143 · 2,842 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lymph Tonic IIECHINACEA (ANGUSTIFOLIA), COLLINSONIA CANADENSIS, PHYTOLACCA DECANDRA, KALI IODATUM, PINUS SYLVESTRIS, PIX LIQUIDA, FERRUM PHOSPHORICUM, AESCULUS HIPPOCASTANUM, BARYTA CARBONICA, BERBERIS VULGARIS, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CAUSTICUM, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, NITRICUM ACIDUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEA, STELLARIA MEDIA, SULPHUR, TEREBINTHINA, THUJA OCCIDENTALIS, BUFO RANABioActive Nutritional, Inc.0e3265b0-b210-4a4c-80d2-8a9712981d4e2026-09-17WarningsExact identifier
unii: ETJ7Z6XBU4
dicyclomine hydrochlorideDICYCLOMINE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.6d7e73b0-3f7e-462f-92eb-cc82919c80952026-09-10Warnings, Adverse reactionsExact identifier
unii: CQ903KQA31
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDEREMEDYREPACK INC.62be6437-db8c-431b-8e5f-780487cf2d432026-09-09Warnings, Adverse reactionsExact identifier
application number: ANDA040317
unii: CQ903KQA31
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDEREMEDYREPACK INC.e67ad329-6395-4fa0-a898-f13959034e262026-09-04Warnings, Adverse reactionsExact identifier
application number: ANDA040319
unii: CQ903KQA31
Psoriasis ControlCENTELLA ASIATICA, SODIUM CHLORIDE, AND SILICON DIOXIDEForces of Nature2db33771-0bb9-49f8-84fa-dddc28e4ba262026-09-04WarningsExact identifier
unii: ETJ7Z6XBU4
BMNP SiliceaSILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro5a58454f-aed6-24ba-e063-6294a90a47fb2026-08-31WarningsExact identifier
unii: ETJ7Z6XBU4
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
Argentum QuartzARGENTUM QUARTZUriel Pharmacy Inc.765c8c8f-0727-45da-a77e-c3907a3d07932026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
Endometrium ArgentumENDOMETRIUM ARGENTUMUriel Pharmacy Incd2d1428a-c8b5-9529-e053-2995a90a23432026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
S12 AIRBORNEALFALFA, ALLIUM SATIVUM, ARSENICUM IODATUM, BARLEY, BETULA PUBESCENS, BROWN RICE, CORN GRAIN, EUPHRASIA OFFICINALIS, FEATHER MIX, HAIR MIX, HISTAMINUM, HOUSE DUST MITE, LOLIUM PERENNE, OAT, PERFOLIATE HONEYSUCKLE, PHLEUM PRATENSE, POLLEN MIX, RYE, SABADILLA, SILICEA, SKIN MIX, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, TEREBINTHINA, WHEATApex Energetics Inc.bb0036c3-1e4d-5750-e053-2995a90ae8952026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
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
Aging Eye FormulaCINERARIA MARITIMA, EYE (SUIS), CALCAREA FLUORICA, CAUSTICUM, PHOSPHORUS, SILICEA, ZINCUM METALLICUM, GERMANIUM METALLICUM, NATRUM MURIATICUMNutritional Specialties, Inc.d5b44f79-5299-4b31-ba45-0e511cdbe17c2026-08-24WarningsExact identifier
unii: ETJ7Z6XBU4
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDEREMEDYREPACK INC.7ff96d1f-fb87-4244-a697-1d93e10eb7382026-08-21Warnings, Adverse reactionsExact identifier
unii: CQ903KQA31
Rohto Optic GlowNAPHAZOLINE HYDROCHLORIDE, POVIDONE, PROPYLENE GLYCOLThe Mentholatum Companydf9c5f7c-96e6-4b2b-b8cb-21a6a3342dff2026-08-20WarningsExact identifier
unii: 6DC9Q167V3
Bio Combination 28SCHUESSLER SALTSLDD Bioscience Private Limited597caf33-5107-9dec-e063-6294a90a5fcd2026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4
Sweat Resistant Sunscreen Body OriginalTITANIUM DIOXIDE, ZINC OXIDEClutch, Inc.4bbde755-e312-123e-e063-6294a90a467f2026-08-20WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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