Home NDC 17856-2261 Dicyclomine Hydrochloride
Product NDC 17856-2261
11-digit product format 178562261
Labeler code 17856
Product ID 17856-2261_362374f1-a8ef-120d-e063-6394a90a0d6d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dicyclomine Hydrochloride
Dosage form SOLUTION
Route ORAL
Labeler ATLANTIC BIOLOGICALS CORP.
Application ANDA214721
Marketing category ANDA
Marketing start 2025-03-04
Substance DICYCLOMINE HYDROCHLORIDE
Active strength 10 mg/5mL
Pharmacologic classes Anticholinergic [EPC], Cholinergic Antagonists [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A214721-001 DICYCLOMINE HYDROCHLORIDE DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2021-04-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A214721-001 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 2026-08-18 06:07:40 2026-07 A214721-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2021-04-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A214721-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2021-04-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214721-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2021-04-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214721-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2021-04-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214721-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2021-04-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214721-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2021-04-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214721-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2021-04-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214721-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2021-04-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214721-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2021-04-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214721-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2021-04-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214721-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2021-04-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214721-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2021-04-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214721-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2021-04-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214721-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2021-04-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A214721-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2021-04-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A214721-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2021-04-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A214721-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2021-04-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A214721-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2021-04-23 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A214721-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2021-04-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A214721-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2021-04-23 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A214721-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2021-04-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A214721-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2021-04-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A214721-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2021-04-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A214721-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2021-04-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A214721-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2021-04-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A214721-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2021-04-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A214721-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2021-04-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A214721-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2021-04-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A214721-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2021-04-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A214721-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2021-04-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A214721-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2021-04-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A214721-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2021-04-23 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A214721-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2021-04-23 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214721-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA 2021-04-23 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Dicyclomine Hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DICYCLOMINE HYDROCHLORIDE 10 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination CQ903KQA31 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 991082 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 17856-2261-1 Dicyclomine Hydrochloride 72 mL in 1 BOX, UNIT-DOSE SOLUTION 72 3 17856-2261-2 Dicyclomine Hydrochloride 72 mL in 1 BOX, UNIT-DOSE SOLUTION 72 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 17856-2261 DICYCLOMINE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORP.] 3 Current NDC, 2 package rows 20250529_2f89e438-6a8a-917e-e063-6294a90a1c23.zip
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 1 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 17856-2261-1 17856226101 72 mL in 1 BOX, UNIT-DOSE (17856-2261-1) 72 ml 2025-03-04 No No Current 17856-2261-2 17856226102 72 mL in 1 BOX, UNIT-DOSE (17856-2261-2) 72 ml 2025-03-04 No No Current