Dicyclomine Hydrochloride

Product NDC: 53808-1055
11-digit product format: 538081055
Labeler code: 53808
Product ID: 53808-1055_da42f97f-21e6-4847-9b8d-9975b6be3ccc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dicyclomine Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: State of Florida DOH Central Pharmacy
Application: ANDA040204
Marketing category: ANDA
Marketing start: 2013-01-01
Marketing end: 0000-00-00
Substance: DICYCLOMINE HYDROCHLORIDE
Active strength: 10 mg/1
Pharmacologic classes: Anticholinergic [EPC],Cholinergic Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2019-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	53808-1055		I	Inactivated by FDA		2026-08-17
excluded package	package	53808-1055	53808-1055-2	I	Inactivated by FDA		2026-08-17

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 · 42 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53808-1055-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53808-1055-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53808-1055-2	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53808-1055-2	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53808-1055-2	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53808-1055-2	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53808-1055-2	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53808-1055-2	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53808-1055-2	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	53808-1055-2	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	53808-1055-2	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	53808-1055-2	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	53808-1055-2	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	53808-1055-2	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	53808-1055-2	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	53808-1055-2	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	53808-1055-2	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	53808-1055-2	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	53808-1055-2	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	53808-1055-2	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	53808-1055-2	`9bebd1f3094a…`	`5416666fcb17…`

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
A040204-001	DICYCLOMINE HYDROCHLORIDE	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB		1997-02-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040204-001	AB

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A040204-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1997-02-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040204-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1997-02-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040204-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1997-02-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040204-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1997-02-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040204-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1997-02-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040204-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1997-02-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040204-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1997-02-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040204-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1997-02-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040204-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1997-02-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040204-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1997-02-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040204-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1997-02-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040204-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1997-02-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040204-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1997-02-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040204-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1997-02-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040204-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1997-02-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040204-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1997-02-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040204-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1997-02-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040204-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1997-02-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040204-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1997-02-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040204-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1997-02-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040204-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1997-02-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040204-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1997-02-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040204-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1997-02-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040204-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1997-02-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040204-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1997-02-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040204-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1997-02-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040204-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1997-02-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040204-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1997-02-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040204-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1997-02-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040204-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1997-02-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040204-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1997-02-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040204-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1997-02-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040204-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1997-02-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040204-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1997-02-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040204-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1997-02-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040204-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1997-02-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040204-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1997-02-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040204-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1997-02-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040204-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1997-02-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040204-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	1997-02-28	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A040204-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040204-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040204-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040204-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040204-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040204-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040204-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040204-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040204-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040204-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040204-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040204-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040204-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040204-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040204-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040204-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040204-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040204-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040204-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040204-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040204-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040204-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040204-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040204-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040204-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040204-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040204-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040204-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040204-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040204-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040204-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040204-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040204-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040204-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040204-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040204-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040204-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040204-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040204-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040204-001	AB	1	`e64feba35796…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f755a917-03bc-45af-a1e3-50286868bfdb	Product name	9	20250303
f27796e1-d653-495b-932a-f51768e9be8a	Product name	2	20211021

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53808-1055-2	2020-01-31	C162847	48780-1	9d75b9d0-39af-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use BENTYL safely and effectively. See full prescribing information for dicyclomine hydrochloride. Dicyclomine Hydrochloride Capsules, USP for oral use Dicyclomine Hydrochloride Tablets, USP for oral use Initial U.S. Approval: 1950

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53808-1055-2	Dicyclomine Hydrochloride	30 in 1 BLISTER PACK	CAPSULE	30		3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DICYCLOMINE HYDROCHLORIDE	ACTIVE INGREDIENT	CQ903KQA31	DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	3
DICYCLOMINE	ACTIVE MOIETY	4KV4X8IF6V	DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	3
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	3
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	3
FD&C RED NO. 4	INACTIVE INGREDIENT	X3W0AM1JLX	DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	3
GELATIN	INACTIVE INGREDIENT	2G86QN327L	DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53808-1055	DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	3	Legacy NDC, 1 package rows	20141024_88942e82-b798-4122-9ea2-0932ef09357f.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dicyclomine hydrochloride	DICYCLOMINE HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	a16e7b6b-dbc9-463d-9bde-dba4f25589cf	2024-08-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040204 application number: ANDA040204
Dicyclomine hydrochloride	DICYCLOMINE HYDROCHLORIDE	Golden State Medical Supply, Inc.	01413a77-48f8-1a8a-e063-6394a90ae494	2023-07-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040204 application number: ANDA040204
Dicyclomine hydrochloride	DICYCLOMINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	99d7d1ce-47b5-4bbd-afe0-908505a9a51b	2023-06-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040204 application number: ANDA040204

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
CQ903KQA31	DICYCLOMINE HYDROCHLORIDE	67-92-5	DICYCLOMINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
991061	dicyclomine HCl 10 MG Oral Capsule	PSN	88942e82-b798-4122-9ea2-0932ef09357f	3
991086	dicyclomine HCl 20 MG Oral Tablet	PSN	88942e82-b798-4122-9ea2-0932ef09357f	3
991061	dicyclomine hydrochloride 10 MG Oral Capsule	SCD	88942e82-b798-4122-9ea2-0932ef09357f	3
991086	dicyclomine hydrochloride 20 MG Oral Tablet	SCD	88942e82-b798-4122-9ea2-0932ef09357f	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
53808-1055-2	53808105502	30 in 1 BLISTER PACK	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dicyclomine Hydrochloride	State of Florida DOH Central Pharmacy	2014-10-21	HUMAN PRESCRIPTION DRUG LABEL	3