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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 28 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-01-11 03:41 UTC · source 2025-01-10 excluded product product I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 53703-800-16 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 53703-800-16 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 53703-800-16 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 53703-800-16 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 53703-800-16 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 53703-800-16 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 53703-800-16 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 53703-800-16 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 53703-800-16 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 53703-800-16 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 53703-800-16 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 53703-800-16 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 53703-800-16 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 53703-800-16 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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.
Product history page 1 of 2 · 43 observed 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 2026-09-14 22:38:34 2026-08 A040169-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 2005-03-24 84e616aacf4f…2026-08-18 06:07:40 2026-07 A040169-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 2005-03-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A040169-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 2005-03-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040169-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 2005-03-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040169-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 2005-03-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040169-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 2005-03-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040169-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 2005-03-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040169-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 2005-03-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040169-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 2005-03-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040169-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 2005-03-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040169-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 2005-03-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040169-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 2005-03-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040169-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 2005-03-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040169-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 2005-03-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040169-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 2005-03-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040169-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 2005-03-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040169-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 2005-03-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040169-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 2005-03-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040169-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 2005-03-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040169-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL RS 2005-03-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040169-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 2005-03-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040169-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 2005-03-24 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040169-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 2005-03-24 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040169-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 2005-03-24 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040169-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 2005-03-24 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040169-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 2005-03-24 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040169-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL RS 2005-03-24 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040169-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL RS 2005-03-24 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040169-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL RS 2005-03-24 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040169-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 2005-03-24 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040169-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 2005-03-24 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040169-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 2005-03-24 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040169-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 2005-03-24 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040169-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 2005-03-24 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040169-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 2005-03-24 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040169-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 2005-03-24 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040169-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 2005-03-24 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040169-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 2005-03-24 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040169-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 2005-03-24 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040169-001 DICYCLOMINE HYDROCHLORIDE 10MG/5ML SYRUP / ORAL AA RS 2005-03-24 f41ea6bd6efb…
Observed Orange Book normalized TE history# 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
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 · 1 matching rows.