Dicyclomine Hydrochloride

Product NDC: 0378-1620
11-digit product format: 003781620
Labeler code: 0378
Product ID: 0378-1620_9923776f-ab42-4f59-971e-542147dd6b7c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: dicyclomine hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Mylan Pharmaceuticals Inc.
Application: ANDA040317
Marketing category: ANDA
Marketing start: 1999-11-03
Marketing end: 0000-00-00
Substance: DICYCLOMINE HYDROCHLORIDE
Active strength: 20 mg/1
Pharmacologic classes: Anticholinergic [EPC],Cholinergic Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2020-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0378-1620		D	Discontinued by firm	2026-08-17
excluded package	package	0378-1620	0378-1620-01	D	Discontinued by firm	2026-08-17
excluded package	package	0378-1620	0378-1620-05	D	Discontinued by firm	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 · 36 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	0378-1620-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0378-1620-05	`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	0378-1620-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0378-1620-05	`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	0378-1620-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0378-1620-05	`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	0378-1620-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0378-1620-05	`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	0378-1620-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0378-1620-05	`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	0378-1620-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0378-1620-05	`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	0378-1620-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0378-1620-05	`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	0378-1620-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0378-1620-05	`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	0378-1620-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0378-1620-05	`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	0378-1620-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0378-1620-05	`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	0378-1620-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0378-1620-05	`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	0378-1620-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0378-1620-05	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A040317-001	DICYCLOMINE HYDROCHLORIDE	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB		1999-09-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040317-001	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	A040317-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-09-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040317-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-09-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040317-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-09-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040317-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-09-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040317-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-09-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040317-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-09-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040317-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-09-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040317-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-09-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040317-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-09-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040317-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-09-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040317-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-09-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040317-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-09-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040317-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-09-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040317-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-09-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040317-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-09-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040317-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL		1999-09-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040317-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL		1999-09-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040317-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL		1999-09-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040317-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-09-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040317-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL		1999-09-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040317-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL		1999-09-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040317-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-09-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040317-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-09-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040317-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-09-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040317-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-09-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040317-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-09-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040317-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-09-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040317-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-09-07	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040317-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-09-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040317-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-09-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040317-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-09-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040317-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-09-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040317-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-09-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040317-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-09-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040317-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-09-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040317-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1999-09-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040317-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL		1999-09-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040317-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL		1999-09-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040317-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL		1999-09-07	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040317-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL		1999-09-07	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A040317-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040317-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040317-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040317-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040317-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040317-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040317-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040317-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040317-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040317-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040317-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040317-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040317-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040317-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040317-001	AB	1	`8072bd15b7f6…`
2019-12-13 00:20 UTC	2019-12	A040317-001	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040317-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040317-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040317-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040317-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040317-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040317-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040317-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040317-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040317-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040317-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040317-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040317-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040317-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040317-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040317-001	AB	1	`053a50430f4f…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A040317-001	AB	1	`a50c72e98297…`

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-1620-01	EA - Each	0378-1620	cfcf4714-4785-4dc6-bd48-94a3f275c24f	1	2012-07-24
0378-1620-05	EA - Each	0378-1620	9b1514de-a954-4f8f-8428-ee2ec7e995b9	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DICYCLOMINE HYDROCHLORIDE	ACTIVE INGREDIENT	CQ903KQA31	DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.]	4
DICYCLOMINE	ACTIVE MOIETY	4KV4X8IF6V	DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.]	4
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.]	4
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.]	4
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.]	4
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.]	4
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.]	4
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.]	4
GELATIN	INACTIVE INGREDIENT	2G86QN327L	DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.]	4
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.]	4
SHELLAC	INACTIVE INGREDIENT	46N107B71O	DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.]	4
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.]	4
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.]	4
DICYCLOMINE HYDROCHLORIDE	ACTIVE INGREDIENT	CQ903KQA31	DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]	3
DICYCLOMINE	ACTIVE MOIETY	4KV4X8IF6V	DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]	3
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]	3
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]	3
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]	3
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]	3
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]	3
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]	3
GELATIN	INACTIVE INGREDIENT	2G86QN327L	DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]	3
SHELLAC	INACTIVE INGREDIENT	46N107B71O	DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]	3
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DICYCLOMINE HYDROCHLORIDE CAPSULE DICYCLOMINE HYDROCHLORIDE TABLET [MYLAN INSTITUTIONAL INC.]	3
DICYCLOMINE HYDROCHLORIDE	ACTIVE INGREDIENT	CQ903KQA31	DICYCLOMINE HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS INC.]	1
DICYCLOMINE	ACTIVE MOIETY	4KV4X8IF6V	DICYCLOMINE HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS INC.]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	DICYCLOMINE HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DICYCLOMINE HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS INC.]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DICYCLOMINE HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DICYCLOMINE HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DICYCLOMINE HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS INC.]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	DICYCLOMINE HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	DICYCLOMINE HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS 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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	1b2d5256-b75d-11f8-e063-6394a90ae9ed	2026-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040317 application number: ANDA040317
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Unit Dose Solutions, Inc.	5370e633-53a3-3764-e063-6394a90a3cad	2026-06-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040317 application number: ANDA040317
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Coupler LLC	5025a55d-ff55-c810-e063-6294a90adfb3	2026-04-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040317 application number: ANDA040317
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Bryant Ranch Prepack	5734fac5-893d-4afd-95a1-e7ab4fd1df3a	2026-04-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040317 application number: ANDA040317
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Redpharm Drug	3252540c-980d-40ca-e063-6394a90ad1c9	2025-12-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040317 application number: ANDA040317
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	REMEDYREPACK INC.	62be6437-db8c-431b-8e5f-780487cf2d43	2025-07-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040317 application number: ANDA040317
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	1b420733-b3b7-e504-e063-6394a90abba7	2024-06-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040317 application number: ANDA040317
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Bryant Ranch Prepack	226a3a6e-9419-448a-827f-01199b792762	2024-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040317 application number: ANDA040317
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	0d07a460-5cb1-cd4b-e063-6294a90a291d	2024-02-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040317 application number: ANDA040317
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Aurobindo Pharma Limited	d81b93f8-bebc-455e-82b6-9a3de3f82e92	2023-05-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040317 application number: ANDA040317

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	dac1bf89-575b-442e-99ff-6f94da4d872e	15
991086	dicyclomine HCl 20 MG Oral Tablet	PSN	dac1bf89-575b-442e-99ff-6f94da4d872e	15
991061	dicyclomine hydrochloride 10 MG Oral Capsule	SCD	dac1bf89-575b-442e-99ff-6f94da4d872e	15
991086	dicyclomine hydrochloride 20 MG Oral Tablet	SCD	dac1bf89-575b-442e-99ff-6f94da4d872e	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0378-1620-01	00378162001	100 TABLET in 1 BOTTLE, PLASTIC (0378-1620-01)	100 tablet	1999-11-03	0000-00-00	No	No	Current
0378-1620-05	00378162005	500 TABLET in 1 BOTTLE, PLASTIC (0378-1620-05)	500 tablet	1999-11-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dicyclomine Hydrochloride	Preferred Pharmaceuticals Inc.	2021-04-22	HUMAN PRESCRIPTION DRUG LABEL	7
Dicyclomine Hydrochloride	REMEDYREPACK INC.	2021-03-05	HUMAN PRESCRIPTION DRUG LABEL	7
Dicyclomine Hydrochloride	Mylan Institutional Inc.	2020-02-07	HUMAN PRESCRIPTION DRUG LABEL	9
Dicyclomine Hydrochloride - RedPharm Drug, Inc.	RedPharm Drug, Inc.	2020-01-20	HUMAN PRESCRIPTION DRUG LABEL	3
Dicyclomine Hydrochloride	A-S Medication Solutions	2020-01-18	HUMAN PRESCRIPTION DRUG LABEL	15
Dicyclomine Hydrochloride	A-S Medication Solutions	2020-01-18	HUMAN PRESCRIPTION DRUG LABEL	12
Dicyclomine Hydrochloride	REMEDYREPACK INC.	2019-07-22	HUMAN PRESCRIPTION DRUG LABEL	3
Dicyclomine Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	2018-08-27	HUMAN PRESCRIPTION DRUG LABEL	1
Dicyclomine Hydrochloride	Mylan Pharmaceuticals Inc.	2016-02-17	HUMAN PRESCRIPTION DRUG LABEL	10