FDA.reportPublic FDA data

NDC 50090-0127-01 - 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
50090-0127
Requested NDC
50090-0127-01
Package NDCs from labels
50090-0127-0, 50090-0127-1, 50090-0127-01
Manufacturer
A-S Medication Solutions
Effective date
2023-02-04
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Dicyclomine Hydrochloride - A-S Medication SolutionsA-S Medication Solutions2023-02-04HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
50090-0127-02023-02-07These highlights do not include all the information needed to use DICYCLOMINE HYDROCHLOLRIDE CAPSULES and DICYCLOMINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DICYCLOMINE HYDROCHLOLRIDE CAPSULES and DICYCLOMINE HYDROCHLORIDE TABLETS. DICYCLOMINE HYDROCHLOLRIDE capsules, for oral use DICYCLOMINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1950
50090-0127-12023-02-07These highlights do not include all the information needed to use DICYCLOMINE HYDROCHLOLRIDE CAPSULES and DICYCLOMINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DICYCLOMINE HYDROCHLOLRIDE CAPSULES and DICYCLOMINE HYDROCHLORIDE TABLETS. DICYCLOMINE HYDROCHLOLRIDE capsules, for oral use DICYCLOMINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1950
50090-0127-02023-01-30These highlights do not include all the information needed to use DICYCLOMINE HYDROCHLOLRIDE CAPSULES and DICYCLOMINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DICYCLOMINE HYDROCHLOLRIDE CAPSULES and DICYCLOMINE HYDROCHLORIDE TABLETS. DICYCLOMINE HYDROCHLOLRIDE capsules, for oral use DICYCLOMINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1950
50090-0127-12023-01-30These highlights do not include all the information needed to use DICYCLOMINE HYDROCHLOLRIDE CAPSULES and DICYCLOMINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DICYCLOMINE HYDROCHLOLRIDE CAPSULES and DICYCLOMINE HYDROCHLORIDE TABLETS. DICYCLOMINE HYDROCHLOLRIDE capsules, for oral use DICYCLOMINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1950

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0127-0Dicyclomine Hydrochloride30 in 1 BOTTLECAPSULE3017
50090-0127-1Dicyclomine Hydrochloride28 in 1 BOTTLECAPSULE2817

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0127DICYCLOMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS]17Current NDC, Legacy NDC, 2 package rows20230208_5f5d7145-118b-4cab-bfe0-19f7740ef1fe.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0127-1EA - Each50090-0127d97fd89d-692e-414d-a8a4-d6c1f9dfc2bb12021-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DICYCLOMINE HYDROCHLORIDEACTIVE INGREDIENTCQ903KQA31DICYCLOMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
DICYCLOMINEACTIVE MOIETY4KV4X8IF6VDICYCLOMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MDICYCLOMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
AMMONIAINACTIVE INGREDIENT5138Q19F1XDICYCLOMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3DICYCLOMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
CALCIUM SULFATEINACTIVE INGREDIENTWAT0DDB505DICYCLOMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDICYCLOMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYDICYCLOMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
GELATININACTIVE INGREDIENT2G86QN327LDICYCLOMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302DICYCLOMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDICYCLOMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DICYCLOMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DICYCLOMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
SHELLACINACTIVE INGREDIENT46N107B71ODICYCLOMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DICYCLOMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDICYCLOMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS 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 7 of 313 · 6,259 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
hand sanitizer- light purple 01ALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltd.598b7bb8-0d2e-a66f-e063-6294a90a45b82026-08-21WarningsExact identifier
unii: 3K9958V90M
Hand sanitizer disinfectionHAND SANITIZER DISINFECTIONGuangzhou Huanmei Cosmetics Co., Ltd.598bf234-d2da-4e59-e063-6294a90a67e42026-08-21WarningsExact identifier
unii: 3K9958V90M
hand sanitizer- light yellow 01ALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltd.598bf8cd-2a79-8b56-e063-6394a90a42a82026-08-21WarningsExact identifier
unii: 3K9958V90M
hand sanitizer- light pink 01ALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltd.598c41f0-908d-df52-e063-6394a90a3c8d2026-08-21WarningsExact identifier
unii: 3K9958V90M
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDEREMEDYREPACK INC.7ff96d1f-fb87-4244-a697-1d93e10eb7382026-08-21Warnings, Adverse reactionsExact identifier
rxcui: 991086
unii: CQ903KQA31
BCBG GENERATION Hand Sanitizer CARAMEL DREAM SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCOef6fa913-b65d-4b3a-b88a-89cdbbf740492026-08-21WarningsExact identifier
unii: 3K9958V90M
BCBG GENERATION Hand Sanitizer FRESH GUAVA SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCOee59fcad-e88b-4fc0-b71c-724881400a792026-08-21WarningsExact identifier
unii: 3K9958V90M
hand sanitizer strawberry matcha scentETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO42fdd67d-e77c-4d08-9676-f37ec43f7e432026-08-21WarningsExact identifier
unii: 3K9958V90M
Rohto Optic GlowNAPHAZOLINE HYDROCHLORIDE, POVIDONE, PROPYLENE GLYCOLThe Mentholatum Companydf9c5f7c-96e6-4b2b-b8cb-21a6a3342dff2026-08-20WarningsExact identifier
unii: 6DC9Q167V3
Smelling SaltsAMMONIA INHALANT, SMELLING SALTSHodayfa Abu Alkian524e002c-f509-9395-e063-6394a90acd9e2026-08-20WarningsExact identifier
unii: 5138Q19F1X
Bio Combination 28SCHUESSLER SALTSLDD Bioscience Private Limited597caf33-5107-9dec-e063-6294a90a5fcd2026-08-20WarningsExact identifier
unii: WAT0DDB505
unii: ETJ7Z6XBU4
Sweat Resistant Sunscreen Body OriginalTITANIUM DIOXIDE, ZINC OXIDEClutch, Inc.4bbde755-e312-123e-e063-6294a90a467f2026-08-20WarningsExact identifier
unii: 15FIX9V2JP
Psorinum ComplexPHOSPHORUS, SILICEA, SULPHUR, ALOEBioActive Nutritional, Inc.d4746927-e6d4-463d-a084-56ffc48d1e672026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4
Boneforce HPCALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, HYDROFLUORICUM ACIDUM, RHUS TOX, SILICEA, SYMPHYTUM OFFICINALEBioActive Nutritional, Inc.d96ca52b-781d-431c-ad2a-a54fd57eb1062026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDEMajor Pharmaceuticals5eee0dff-d157-4534-adfb-c035b7042c072026-08-20Warnings, Adverse reactionsExact identifier
application number: ANDA084285
rxcui: 991086
rxcui: 991061
unii: CQ903KQA31
WISH ADVANCED HAND SANITIZER SALTED CARAMEL PISTACHIOALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA595f9f2a-7857-0752-e063-6394a90af8de2026-08-19WarningsExact identifier
unii: 3K9958V90M
WISH ADVANCED HAND SANITIZER DRAGONFRUIT JASMINEALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA595fd84a-fead-3818-e063-6394a90aa4f12026-08-19WarningsExact identifier
unii: 3K9958V90M
Smelling SaltsAMMONIA INHALANT, SMELLING SALTSShenzhen Leadtop E-commerce Co.,Ltd.558e8629-6a8d-198d-e063-6294a90ac5fc2026-08-19WarningsExact identifier
unii: 5138Q19F1X
Dicyclomine hydrochlorideDICYCLOMINE HYDROCHLORIDERedpharm Drug594b6832-a31c-4de2-e063-6294a90a05fa2026-08-18Warnings, Adverse reactionsExact identifier
rxcui: 991086
unii: CQ903KQA31
WISH HAND SANITIZER vanilla creamALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA594bb903-2406-abb9-e063-6294a90a1cee2026-08-18WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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