FDA.reportPublic FDA data

dicyclomine hydrochloride

Product NDC
17856-1161
11-digit product format
178561161
Labeler code
17856
Product ID
17856-1161_09e3911c-ccf4-4ba2-a753-5779ec47854c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dicyclomine hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Atlantic Biologicals Corps
Application
ANDA040169
Marketing category
ANDA
Marketing start
2005-06-23
Marketing end
0000-00-00
Substance
DICYCLOMINE HYDROCHLORIDE
Active strength
10 mg/5mL
Pharmacologic classes
Anticholinergic [EPC],Cholinergic Antagonists [MoA]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct17856-1161IInactivated by FDA2026-07-31
excluded packagepackage17856-116117856-1161-1IInactivated by FDA2026-07-31
excluded packagepackage17856-116117856-1161-3IInactivated by FDA2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040169-001DICYCLOMINE HYDROCHLORIDEDICYCLOMINE HYDROCHLORIDE10MG/5MLSYRUP / ORALAARS2005-03-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A040169-001AA

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A040169-001DICYCLOMINE HYDROCHLORIDE10MG/5MLSYRUP / ORALAARS2005-03-24a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A040169-001AA1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
dicyclomine hydrochlorideDICYCLOMINE HYDROCHLORIDEPar Health USA, LLCbb099db9-f635-4a64-8892-6236971dec452026-05-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040169
application number: ANDA040169

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f755a917-03bc-45af-a1e3-50286868bfdbProduct name920250303
f27796e1-d653-495b-932a-f51768e9be8aProduct name220211021

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17856-1161-12020-01-31C16284748780-19d75b9d0-fc9d-f424-e053-dadaa90a57ce95a0f538-4c94-487a-b85f-424eddd59459
17856-1161-32020-01-31C16284748780-19d75b9d0-fc9d-f424-e053-dadaa90a57ce95a0f538-4c94-487a-b85f-424eddd59459

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-1161-1dicyclomine hydrochloride5 mL in 1 CUPSOLUTION53
17856-1161-3dicyclomine hydrochloride10 mL in 1 CUPSOLUTION103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17856-1161-1ML - Milliliter17856-116131ca94a5-a77a-4649-b864-7e4d78310c0b12013-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DICYCLOMINE HYDROCHLORIDEACTIVE INGREDIENTCQ903KQA31DICYCLOMINE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS]2
DICYCLOMINEACTIVE MOIETY4KV4X8IF6VDICYCLOMINE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS]2
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LDICYCLOMINE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDICYCLOMINE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADICYCLOMINE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DICYCLOMINE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDICYCLOMINE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TDICYCLOMINE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DICYCLOMINE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHDICYCLOMINE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS]2
SORBITOLINACTIVE INGREDIENT506T60A25RDICYCLOMINE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS]2
SUCROSEINACTIVE INGREDIENTC151H8M554DICYCLOMINE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS]2
WATERINACTIVE INGREDIENT059QF0KO0RDICYCLOMINE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-1161DICYCLOMINE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS]3Legacy NDC, 2 package rows20160829_95a0f538-4c94-487a-b85f-424eddd59459.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991082dicyclomine HCl 10 MG in 5 mL Oral SolutionPSN95a0f538-4c94-487a-b85f-424eddd594593
991082dicyclomine hydrochloride 2 MG/ML Oral SolutionSCD95a0f538-4c94-487a-b85f-424eddd594593
991082dicyclomine HCl 10 MG per 5 ML Oral SolutionSY95a0f538-4c94-487a-b85f-424eddd594593

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
17856-1161-1178561161015 mL in 1 CUP5 mlHistorical
17856-1161-31785611610310 mL in 1 CUP10 mlHistorical