Home NDC 53703-800 Dicyclomine Hydrochloride
Product NDC 53703-800
11-digit product format 537030800
Labeler code 53703
Product ID 53703-800_a81ed77a-1ea5-4399-a2a4-bf8a3c3240a7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dicyclomine Hydrochloride
Dosage form SYRUP
Route ORAL
Labeler Entera Health, Inc.
Application ANDA040169
Marketing category ANDA
Marketing start 2015-04-27
Marketing end 0000-00-00
Substance DICYCLOMINE HYDROCHLORIDE
Active strength 10 mg/mL
Pharmacologic classes Anticholinergic [EPC],Cholinergic Antagonists [MoA]
NDC exclude flag E
Listing certified through 2018-12-31
Current FDA listing Historical FDA.report record 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A040169-001 DICYCLOMINE HYDROCHLORIDE DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 2005-03-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A040169-001 AA
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 A040169-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 2005-03-24 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A040169-001 AA 1 a50c72e98297…
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.
FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Dicyclomine Hydrochloride ACTIVE INGREDIENT CQ903KQA31 DICYCLOMINE HYDROCHLORIDE SYRUP [ENTERA HEALTH, INC.] 1 Dicyclomine ACTIVE MOIETY 4KV4X8IF6V DICYCLOMINE HYDROCHLORIDE SYRUP [ENTERA HEALTH, INC.] 1 Glycerin INACTIVE INGREDIENT PDC6A3C0OX DICYCLOMINE HYDROCHLORIDE SYRUP [ENTERA HEALTH, INC.] 1 Methylparaben INACTIVE INGREDIENT A2I8C7HI9T DICYCLOMINE HYDROCHLORIDE SYRUP [ENTERA HEALTH, INC.] 1 Propylene Glycol INACTIVE INGREDIENT 6DC9Q167V3 DICYCLOMINE HYDROCHLORIDE SYRUP [ENTERA HEALTH, INC.] 1 Propylparaben INACTIVE INGREDIENT Z8IX2SC1OH DICYCLOMINE HYDROCHLORIDE SYRUP [ENTERA HEALTH, INC.] 1 Sorbitol INACTIVE INGREDIENT 506T60A25R DICYCLOMINE HYDROCHLORIDE SYRUP [ENTERA HEALTH, INC.] 1 Water INACTIVE INGREDIENT 059QF0KO0R DICYCLOMINE HYDROCHLORIDE SYRUP [ENTERA HEALTH, INC.] 1