FDA.reportPublic FDA data

NDC 71335-0425-09 - 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
71335-0425
Requested NDC
71335-0425-09
Package NDCs from labels
71335-0425-1, 71335-0425-2, 71335-0425-3, 71335-0425-4, 71335-0425-5, 71335-0425-6, 71335-0425-7, 71335-0425-8, 71335-0425-9, 71335-0425-09
Manufacturer
Bryant Ranch Prepack
Effective date
2026-07-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Dicyclomine Hydrochloride - Bryant Ranch PrepackBryant Ranch Prepack2026-07-14HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0425-1Dicyclomine Hydrochloride30 in 1 BOTTLETABLET3010
71335-0425-2Dicyclomine Hydrochloride40 in 1 BOTTLETABLET4010
71335-0425-3Dicyclomine Hydrochloride60 in 1 BOTTLETABLET6010
71335-0425-4Dicyclomine Hydrochloride90 in 1 BOTTLETABLET9010
71335-0425-5Dicyclomine Hydrochloride20 in 1 BOTTLETABLET2010
71335-0425-6Dicyclomine Hydrochloride21 in 1 BOTTLETABLET2110
71335-0425-7Dicyclomine Hydrochloride120 in 1 BOTTLETABLET12010
71335-0425-8Dicyclomine Hydrochloride100 in 1 BOTTLETABLET10010
71335-0425-9Dicyclomine Hydrochloride28 in 1 BOTTLETABLET2810

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0425DICYCLOMINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]10Current NDC, Legacy NDC, 9 package rows20240828_34db5a80-f445-41e5-b3c4-4c18abb09c92.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0425-1EA - Each71335-04256e6bc18a-194e-4dab-b14e-40ffbbf028a612018-03-08
71335-0425-2EA - Each71335-0425fec8e589-6229-4e59-9237-fd80268ab1d512018-03-08
71335-0425-3EA - Each71335-0425a239c964-e4cc-48e4-94c7-fcf1d2b0f77e12018-03-08
71335-0425-4EA - Each71335-0425630bd52a-c02c-4a5a-9709-09de7072d32012018-03-08
71335-0425-5EA - Each71335-0425fa5b3465-8208-43f3-8cbc-ce4b5888410412018-03-08
71335-0425-6EA - Each71335-04253c7c6df1-ae12-47f5-937e-94f039c2b67312018-03-08
71335-0425-7EA - Each71335-04250217747d-3b23-4652-be69-c654e4f11ae912018-03-08

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 42 · 832 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
rxcui: 991086
unii: CQ903KQA31
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDEREMEDYREPACK INC.62be6437-db8c-431b-8e5f-780487cf2d432026-09-09Warnings, Adverse reactionsExact identifier
rxcui: 991086
unii: CQ903KQA31
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDEREMEDYREPACK INC.e67ad329-6395-4fa0-a898-f13959034e262026-09-04Warnings, Adverse reactionsExact identifier
rxcui: 991061
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
BMNP ALUMINUM OXIDEALUMINUM OXIDETotal Operations Management LLC DBA:Bestmade Natural Products Micro5a5ad83a-0ecb-21fa-e063-6294a90a14222026-08-31WarningsExact identifier
unii: LMI26O6933
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
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
application number: ANDA040230
rxcui: 991086
unii: CQ903KQA31
Bio Combination 28SCHUESSLER SALTSLDD Bioscience Private Limited597caf33-5107-9dec-e063-6294a90a5fcd2026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4
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: ANDA040230
rxcui: 991086
rxcui: 991061
unii: CQ903KQA31
Dicyclomine hydrochlorideDICYCLOMINE HYDROCHLORIDERedpharm Drug594b6832-a31c-4de2-e063-6294a90a05fa2026-08-18Warnings, Adverse reactionsExact identifier
rxcui: 991086
unii: CQ903KQA31
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDEREMEDYREPACK INC.2c36b79f-153c-446c-899b-6e28ccff1dc82026-08-18Warnings, Adverse reactionsExact identifier
rxcui: 991086
unii: CQ903KQA31
Cerebellum Thalamus A AurmCEREBELLUM THALAMUS A AURUMUriel Pharmacy Inc.e1c395b8-9221-401f-8980-c91ff88434582026-08-17WarningsExact identifier
unii: ETJ7Z6XBU4
BM BM134 DROPSARSENIC ALBUM, HYDRASTIS, MYRISTICA, NITRIC ACID, PAEONIA, RHUS TOX, SILICEABM Private Limited59023500-89be-cc76-e063-6294a90a6e022026-08-14WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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