FDA.reportPublic FDA data

NDC 17856-0623-4 - 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
17856-0623
Requested NDC
17856-0623-4
Package NDCs from labels
17856-0623-3, 17856-0623-1, 17856-0623-4, 17856-0623-2
Manufacturer
ATLANTIC BIOLOGICALS CORP.
Effective date
2024-04-17
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Dicyclomine Hydrochloride - ATLANTIC BIOLOGICALS CORP.ATLANTIC BIOLOGICALS CORP.2024-04-17HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
17856-0623-12024-04-17These highlights do not include all the information needed to use DICYCLOMINE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for DICYCLOMINE HYDROCHLORIDE ORAL SOLUTION. DICYCLOMINE HYDROCHLORIDE oral solution Initial U.S. Approval: 1950
17856-0623-22024-04-17These highlights do not include all the information needed to use DICYCLOMINE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for DICYCLOMINE HYDROCHLORIDE ORAL SOLUTION. DICYCLOMINE HYDROCHLORIDE oral solution Initial U.S. Approval: 1950
17856-0623-12024-01-30These highlights do not include all the information needed to use DICYCLOMINE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for DICYCLOMINE HYDROCHLORIDE ORAL SOLUTION. DICYCLOMINE HYDROCHLORIDE oral solution Initial U.S. Approval: 1950
17856-0623-22024-01-30These highlights do not include all the information needed to use DICYCLOMINE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for DICYCLOMINE HYDROCHLORIDE ORAL SOLUTION. DICYCLOMINE HYDROCHLORIDE oral solution Initial U.S. Approval: 1950
17856-0623-12022-03-04These highlights do not include all the information needed to use DICYCLOMINE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for DICYCLOMINE HYDROCHLORIDE ORAL SOLUTION. DICYCLOMINE HYDROCHLORIDE oral solution Initial U.S. Approval: 1950
17856-0623-22022-03-04These highlights do not include all the information needed to use DICYCLOMINE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for DICYCLOMINE HYDROCHLORIDE ORAL SOLUTION. DICYCLOMINE HYDROCHLORIDE oral solution Initial U.S. Approval: 1950
17856-0623-12022-01-28These highlights do not include all the information needed to use DICYCLOMINE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for DICYCLOMINE HYDROCHLORIDE ORAL SOLUTION. DICYCLOMINE HYDROCHLORIDE oral solution Initial U.S. Approval: 1950
17856-0623-22022-01-28These highlights do not include all the information needed to use DICYCLOMINE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for DICYCLOMINE HYDROCHLORIDE ORAL SOLUTION. DICYCLOMINE HYDROCHLORIDE oral solution Initial U.S. Approval: 1950

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0623-1Dicyclomine Hydrochloride72 in 1 PACKAGESOLUTION724
17856-0623-2Dicyclomine Hydrochloride72 in 1 BOX, UNIT-DOSESOLUTION724
17856-0623-3Dicyclomine Hydrochloride5 mL in 1 CUP, UNIT-DOSESOLUTION54
17856-0623-4Dicyclomine Hydrochloride10 mL in 1 CUP, UNIT-DOSESOLUTION104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0623DICYCLOMINE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORP.]4Legacy NDC, 4 package rows20240418_7b466007-2be7-4f1d-a41b-f71c0c90b69e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17856-0623-1ML - Milliliter17856-0623191eff76-6b84-40f0-8023-ffa5cffa937612021-04-08

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 2 of 38 · 758 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDECardinal Health 107, LLC793a3f0c-ea45-4e28-a98a-610cf9eddad82026-08-12Warnings, Adverse reactionsExact identifier
unii: CQ903KQA31
DICYCLOMINE HYDROCHLORIDEDICYCLOMINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.9d249073-0171-4bb0-8cad-13cb3713159f2026-08-12Warnings, Adverse reactionsExact identifier
unii: CQ903KQA31
Dicyclomine hydrochlorideDICYCLOMINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.de44e605-14a3-4b40-bf1b-2ac857eb7b122026-08-12Warnings, Adverse reactionsExact identifier
unii: CQ903KQA31
Isopathic Phenolic RingsHOMEOPATHIC LIQUIDEnergetix Corporation98a7ca26-ccb7-43c7-bd65-892fcbacc8822026-08-11WarningsExact identifier
unii: C151H8M554
Lipo-ChordACETICUM AC, ACETYLSAL AC, ADRENOCORTICOTROPHIN, ALUMINA, ARSENICUM ALB, BORAGO, CEANOTHUS, CHELIDONIUM MAJ, CHIONANTHUS, CHLORAMPHENICOLUM, CHLORPROMAZINUM, CHOLESTERINUM, CORTISONE ACETICUM, DAMIANA, FOLLICULINUM, FUMARICUM AC, KALI IOD, LYCOPODIUM, NAT SULPHURICUM, NUX VOM, OLEUM MORRHUAE, PETROLEUM, PHENACETINUM, PHOSPHORICUM AC, PHOSPHORUS, PLUMB MET, SACCHARUM OFF, SILICEA, TARAXACUM, THYROIDINUM.Energetix Corporation5c83cbd5-46fb-48a0-a739-ff9c81e7129c2026-08-11WarningsExact identifier
unii: C151H8M554
SYSTANE HYDRATION PF PRESERVATIVE FREEPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.8936f66f-10fe-44ab-a26e-dd8b05dfa9972026-08-10WarningsExact identifier
unii: 6DC9Q167V3
Systane Pro PFPROPYLENE GLYCOLAlcon Laboratories, Inc.23b3515f-fbe5-4398-b2df-8b2eccdd01e22026-08-10WarningsExact identifier
unii: 6DC9Q167V3
Sterile WaterWATERCardinal Health 107, LLC48d75a7c-8329-48a8-bea0-a8c144ddf6372026-08-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDELannett Company, LLCbd2cba10-70ec-4d1f-b46c-53d1de2ee1302026-08-06Warnings, Adverse reactionsExact identifier
unii: CQ903KQA31
Leader Lubricant Eye Drops 30ctPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCARDINAL HEALTH 110, LLC. DBA LEADER8df69f2c-40c4-245c-e053-2a95a90a54062026-08-05WarningsExact identifier
unii: 6DC9Q167V3
CVS GlycerinGLYCERIN SUPPOISITORYCVS Pharmacy, Incca6d13db-60e8-4fcc-b7b3-3eb280b8c4352026-08-04WarningsExact identifier
unii: PDC6A3C0OX
Dicyclomine HydrochlorideDICYCLOMINE HYDROCHLORIDERedpharm Drug57e5f041-9a6e-9d0c-e063-6294a90ab54c2026-07-31Warnings, Adverse reactionsExact identifier
unii: CQ903KQA31
GarzulysINSULIN ASPART-FSANMeitheal Pharmaceuticals Inc.30c64769-d2f7-4604-ac9e-2a6bc09506c92026-07-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
DECONIMO ReconstitutionDECONIMO RECONSTITUTIONImage Amazon LLC57ab9b1c-9a18-3786-e063-6394a90a2c632026-07-28WarningsExact identifier
unii: 059QF0KO0R
IDkit HP ONECITRIC ACID ANHYDROUS AND 13C UREAMeridian Bioscience Israel Ltd8baab7a7-5d20-46ad-9c4a-762992ef6b512026-07-28Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
Topwin Speedy EnemaGLYCERINHealth Chemical Pharmaceutical Co., Ltd3ba8c3d2-1780-42e1-bec5-8f98771d475e2026-07-27WarningsExact identifier
unii: PDC6A3C0OX
NeutraflushEYEWASH STATION ADDITIVE CONCENTRATEAero Healthcare1d9ff2ef-9c9b-f367-e063-6294a90afa0e2026-07-24WarningsExact identifier
unii: 6DC9Q167V3
Dicyclomine hydrochlorideDICYCLOMINE HYDROCHLORIDEAdvagen Pharma Ltd.,a66aa5c7-1fde-42fc-9e1f-7f4cc9adac9c2026-07-22Warnings, Adverse reactionsExact identifier
unii: CQ903KQA31
Droptics Dry Eye ReliefCARBOXYMETHYLCELLULOSE SODIUM,GLYCERIN,POLYSORBATE 80Droptics LLC29d7614b-f4b7-48e2-97c5-d1bff27731d22026-07-22WarningsExact identifier
unii: PDC6A3C0OX
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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