Dicyclomine Hydrochloride

Product NDC: 0440-7384
11-digit product format: 004407384
Labeler code: 0440
Product ID: 0440-7384_6a458cdc-7859-4a91-bb5f-25e7bd91da7a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dicyclomine Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Liberty Pharmaceuticals, Inc.
Application: ANDA084285
Marketing category: ANDA
Marketing start: 1974-09-30
Marketing end: 0000-00-00
Substance: DICYCLOMINE HYDROCHLORIDE
Active strength: 10 mg/1
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#

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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0440-7384		I	Inactivated by FDA	2026-08-10
excluded package	package	0440-7384	0440-7384-04	I	Inactivated by FDA	2026-08-10
excluded package	package	0440-7384	0440-7384-06	I	Inactivated by FDA	2026-08-10
excluded package	package	0440-7384	0440-7384-12	I	Inactivated by FDA	2026-08-10

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 2 · 88 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	0440-7384-12	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0440-7384-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0440-7384-04	`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	0440-7384-12	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0440-7384-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0440-7384-04	`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	0440-7384-12	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0440-7384-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0440-7384-04	`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	0440-7384-12	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0440-7384-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0440-7384-04	`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	0440-7384-12	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0440-7384-06	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0440-7384-04	`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	0440-7384-12	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0440-7384-06	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0440-7384-04	`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	0440-7384-12	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0440-7384-06	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0440-7384-04	`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	0440-7384-12	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0440-7384-06	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0440-7384-04	`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	0440-7384-12	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0440-7384-06	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0440-7384-04	`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	0440-7384-12	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0440-7384-06	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0440-7384-04	`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	0440-7384-12	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0440-7384-06	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0440-7384-04	`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	0440-7384-12	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0440-7384-06	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0440-7384-04	`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	0440-7384-12	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	0440-7384-06	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	0440-7384-04	`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	0440-7384-12	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	0440-7384-06	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	0440-7384-04	`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	0440-7384-12	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	0440-7384-06	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	0440-7384-04	`1332a3947898…`	`d4bfe170f9cd…`

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
A084285-001	DICYCLOMINE HYDROCHLORIDE	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A084285-001	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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A084285-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084285-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A084285-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A084285-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A084285-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A084285-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A084285-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A084285-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A084285-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A084285-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A084285-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A084285-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A084285-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A084285-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A084285-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A084285-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A084285-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A084285-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A084285-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A084285-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A084285-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A084285-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A084285-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A084285-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A084285-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A084285-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A084285-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A084285-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A084285-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A084285-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A084285-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A084285-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A084285-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A084285-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A084285-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A084285-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A084285-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A084285-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A084285-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A084285-001	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A084285-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084285-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A084285-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A084285-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A084285-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A084285-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A084285-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A084285-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A084285-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A084285-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A084285-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A084285-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A084285-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A084285-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A084285-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A084285-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A084285-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A084285-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A084285-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A084285-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A084285-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A084285-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A084285-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A084285-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A084285-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A084285-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A084285-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A084285-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A084285-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A084285-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A084285-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A084285-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A084285-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A084285-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A084285-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A084285-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A084285-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A084285-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A084285-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A084285-001	AB	1	`cb3db0bc1861…`

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
0440-7384-04	2020-01-31	C162847	48780-1	9d75b9d0-76a5-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use dicyclomine hydrochloride capsules, USP and dicyclomine hydrochloride tablets, USP safely and effectively. See full prescribing information for dicyclomine hydrochloride capsules, USP and dicyclomine hydrochloride tablets, USP. Dicyclomine hydrochloride capsules USP, for oral use Dicyclomine hydrochloride tablets USP, for oral use Initial U.S. Approval: 1950
0440-7384-06	2020-01-31	C162847	48780-1	9d75b9d0-76a5-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use dicyclomine hydrochloride capsules, USP and dicyclomine hydrochloride tablets, USP safely and effectively. See full prescribing information for dicyclomine hydrochloride capsules, USP and dicyclomine hydrochloride tablets, USP. Dicyclomine hydrochloride capsules USP, for oral use Dicyclomine hydrochloride tablets USP, for oral use Initial U.S. Approval: 1950
0440-7384-12	2020-01-31	C162847	48780-1	9d75b9d0-76a5-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use dicyclomine hydrochloride capsules, USP and dicyclomine hydrochloride tablets, USP safely and effectively. See full prescribing information for dicyclomine hydrochloride capsules, USP and dicyclomine hydrochloride tablets, USP. 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	SPL version
0440-7384-04	Dicyclomine Hydrochloride	4 in 1 BOTTLE, PLASTIC	CAPSULE	4	1
0440-7384-06	Dicyclomine Hydrochloride	6 in 1 BOTTLE, PLASTIC	CAPSULE	6	1
0440-7384-12	Dicyclomine Hydrochloride	12 in 1 BOTTLE, PLASTIC	CAPSULE	12	1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DICYCLOMINE HYDROCHLORIDE	ACTIVE INGREDIENT	CQ903KQA31	DICYCLOMINE HYDROCHLORIDE CAPSULE [LIBERTY PHARMACEUTICALS, INC.]	1
DICYCLOMINE	ACTIVE MOIETY	4KV4X8IF6V	DICYCLOMINE HYDROCHLORIDE CAPSULE [LIBERTY PHARMACEUTICALS, INC.]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	DICYCLOMINE HYDROCHLORIDE CAPSULE [LIBERTY PHARMACEUTICALS, INC.]	1
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	DICYCLOMINE HYDROCHLORIDE CAPSULE [LIBERTY PHARMACEUTICALS, INC.]	1
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	DICYCLOMINE HYDROCHLORIDE CAPSULE [LIBERTY PHARMACEUTICALS, INC.]	1
CALCIUM SULFATE	INACTIVE INGREDIENT	WAT0DDB505	DICYCLOMINE HYDROCHLORIDE CAPSULE [LIBERTY PHARMACEUTICALS, INC.]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DICYCLOMINE HYDROCHLORIDE CAPSULE [LIBERTY PHARMACEUTICALS, INC.]	1
FD&C RED NO. 3	INACTIVE INGREDIENT	PN2ZH5LOQY	DICYCLOMINE HYDROCHLORIDE CAPSULE [LIBERTY PHARMACEUTICALS, INC.]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	DICYCLOMINE HYDROCHLORIDE CAPSULE [LIBERTY PHARMACEUTICALS, INC.]	1
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	DICYCLOMINE HYDROCHLORIDE CAPSULE [LIBERTY PHARMACEUTICALS, INC.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	DICYCLOMINE HYDROCHLORIDE CAPSULE [LIBERTY PHARMACEUTICALS, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DICYCLOMINE HYDROCHLORIDE CAPSULE [LIBERTY PHARMACEUTICALS, INC.]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	DICYCLOMINE HYDROCHLORIDE CAPSULE [LIBERTY PHARMACEUTICALS, INC.]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	DICYCLOMINE HYDROCHLORIDE CAPSULE [LIBERTY PHARMACEUTICALS, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DICYCLOMINE HYDROCHLORIDE CAPSULE [LIBERTY PHARMACEUTICALS, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DICYCLOMINE HYDROCHLORIDE CAPSULE [LIBERTY PHARMACEUTICALS, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0440-7384	DICYCLOMINE HYDROCHLORIDE CAPSULE [LIBERTY PHARMACEUTICALS, INC.]	1	Legacy NDC, 3 package rows	20140211_59b4c00d-74cd-44a6-a76c-d44e93bbeca9.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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Bryant Ranch Prepack	4da6868f-3530-4960-af71-e56439c96e9f	2026-07-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084285 application number: ANDA084285
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Major Pharmaceuticals	5eee0dff-d157-4534-adfb-c035b7042c07	2026-06-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084285 application number: ANDA084285
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Lannett Company, Inc.	bd2cba10-70ec-4d1f-b46c-53d1de2ee130	2026-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084285 application number: ANDA084285
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Cardinal Health 107, LLC	63b207da-159c-4cb5-8b06-616ed4811c12	2026-05-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084285 application number: ANDA084285
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Cardinal Health 107, LLC	793a3f0c-ea45-4e28-a98a-610cf9eddad8	2026-04-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084285 application number: ANDA084285
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Proficient Rx LP	3b7145d7-1ba7-45c1-8202-b8fc575d5a8e	2025-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084285 application number: ANDA084285
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Chartwell RX, LLC	d628ac1c-404d-45eb-8aab-0e550c95ed4a	2024-10-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084285 application number: ANDA084285
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	American Health Packaging	833c5d7c-85ca-4ce3-bcd8-5e5b4ecbffe8	2024-08-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084285 application number: ANDA084285
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	7c75f650-c97d-06fa-e053-2991aa0a43bb	2024-07-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084285 application number: ANDA084285
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	A-S Medication Solutions	b3c9dc85-2c6c-44f0-9c98-02673af934cb	2024-02-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084285 application number: ANDA084285
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	A-S Medication Solutions	5f5d7145-118b-4cab-bfe0-19f7740ef1fe	2023-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084285 application number: ANDA084285
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	860e8ea6-6f9b-4fe6-a23d-3600b69c0b35	2019-04-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084285 application number: ANDA084285

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	59b4c00d-74cd-44a6-a76c-d44e93bbeca9	1
991061	dicyclomine hydrochloride 10 MG Oral Capsule	SCD	59b4c00d-74cd-44a6-a76c-d44e93bbeca9	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
0440-7384-04	00440738404	4 in 1 BOTTLE, PLASTIC	Historical
0440-7384-06	00440738406	6 in 1 BOTTLE, PLASTIC	Historical
0440-7384-12	00440738412	12 in 1 BOTTLE, PLASTIC	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dicyclomine Hydrochloride	Liberty Pharmaceuticals, Inc.	2014-02-10	HUMAN PRESCRIPTION DRUG LABEL	1