Dicyclomine

Product NDC: 52959-221
11-digit product format: 529590221
Labeler code: 52959
Product ID: 52959-221_c5e71cb1-0d6c-47fa-b809-2182932ab3db
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dicyclomine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: H.J. Harkins Company, Inc.
Application: ANDA040161
Marketing category: ANDA
Marketing start: 1996-10-01
Marketing end: 0000-00-00
Substance: DICYCLOMINE HYDROCHLORIDE
Active strength: 20 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	52959-221		I	Inactivated by FDA	2026-10-16
excluded package	package	52959-221	52959-221-00	I	Inactivated by FDA	2026-10-16
excluded package	package	52959-221	52959-221-20	I	Inactivated by FDA	2026-10-16
excluded package	package	52959-221	52959-221-30	I	Inactivated by FDA	2026-10-16

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	52959-221-20	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-221-00	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-221-30	`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	52959-221-20	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-221-00	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-221-30	`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	52959-221-20	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-221-00	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-221-30	`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	52959-221-20	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-221-00	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-221-30	`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	52959-221-20	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-221-00	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-221-30	`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	52959-221-20	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-221-00	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-221-30	`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	52959-221-20	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52959-221-00	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52959-221-30	`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	52959-221-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52959-221-00	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52959-221-30	`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	52959-221-20	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	52959-221-00	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	52959-221-30	`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	52959-221-20	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	52959-221-00	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	52959-221-30	`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	52959-221-20	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	52959-221-00	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	52959-221-30	`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	52959-221-20	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	52959-221-00	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	52959-221-30	`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	52959-221-20	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	52959-221-00	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	52959-221-30	`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	52959-221-20	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	52959-221-00	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	52959-221-30	`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	52959-221-20	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	52959-221-00	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	52959-221-30	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A040161-001	DICYCLOMINE HYDROCHLORIDE	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB		1996-10-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040161-001	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 · 44 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
2026-10-15 13:18:30	2026-09	A040161-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1996-10-01	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A040161-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1996-10-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040161-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1996-10-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040161-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1996-10-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040161-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1996-10-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040161-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1996-10-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040161-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1996-10-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040161-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1996-10-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040161-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1996-10-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040161-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1996-10-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040161-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1996-10-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040161-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1996-10-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040161-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1996-10-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040161-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1996-10-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040161-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1996-10-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040161-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1996-10-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040161-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1996-10-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040161-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1996-10-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040161-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1996-10-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040161-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1996-10-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040161-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1996-10-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040161-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1996-10-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040161-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1996-10-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040161-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1996-10-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040161-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1996-10-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040161-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1996-10-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040161-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1996-10-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040161-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1996-10-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040161-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1996-10-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040161-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1996-10-01	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040161-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1996-10-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040161-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1996-10-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040161-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1996-10-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040161-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1996-10-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040161-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1996-10-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040161-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1996-10-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040161-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1996-10-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040161-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1996-10-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040161-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1996-10-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040161-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1996-10-01	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-10-28 04:53 UTC	2022-10	A040161-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040161-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040161-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A040161-001	AB	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
52959-221-00	2020-01-31	C162847	48780-1	9d75b9cf-e7e3-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
52959-221-20	2020-01-31	C162847	48780-1	9d75b9cf-e7e3-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
52959-221-30	2020-01-31	C162847	48780-1	9d75b9cf-e7e3-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	SPL version
52959-221-00	Dicyclomine	100 in 1 BOTTLE, PLASTIC	TABLET	100	1
52959-221-20	Dicyclomine	20 in 1 BOTTLE, PLASTIC	TABLET	20	1
52959-221-30	Dicyclomine	30 in 1 BOTTLE, PLASTIC	TABLET	30	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52959-221-00	EA - Each	52959-221	5f47d742-fc37-4cc9-b154-4e85e74ebb61	1	2012-07-24
52959-221-20	EA - Each	52959-221	729867b4-cc2d-4c04-a6fa-3596a7d0da1e	1	2012-07-24
52959-221-30	EA - Each	52959-221	14388e5e-90da-4f28-849f-b8828697d0fb	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DICYCLOMINE HYDROCHLORIDE	ACTIVE INGREDIENT	CQ903KQA31	DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [H.J. HARKINS COMPANY, INC.]	1
DICYCLOMINE	ACTIVE MOIETY	4KV4X8IF6V	DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [H.J. HARKINS COMPANY, INC.]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [H.J. HARKINS COMPANY, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [H.J. HARKINS COMPANY, INC.]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [H.J. HARKINS COMPANY, INC.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [H.J. HARKINS COMPANY, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [H.J. HARKINS COMPANY, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52959-221	DICYCLOMINE (DICYCLOMINE HYDROCHLORIDE) TABLET [H.J. HARKINS COMPANY, INC.]	1	Legacy NDC, 3 package rows	20120215_aa8350bd-f832-4983-baed-2a6978819b49.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	Hikma Pharmaceuticals USA Inc.	6d7e73b0-3f7e-462f-92eb-cc82919c8095	2026-09-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040161 application number: ANDA040161
Dicyclomine	DICYCLOMINE HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	2c656550-7e5b-445f-e063-6294a90a8f52	2025-02-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040161 application number: ANDA040161
Dicyclomine	DICYCLOMINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	5a553bda-1e3d-4b80-913f-73dd54655033	2021-11-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040161 application number: ANDA040161

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
991086	dicyclomine HCl 20 MG Oral Tablet	PSN	aa8350bd-f832-4983-baed-2a6978819b49	1
991086	dicyclomine hydrochloride 20 MG Oral Tablet	SCD	aa8350bd-f832-4983-baed-2a6978819b49	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
52959-221-00	52959022100	100 in 1 BOTTLE, PLASTIC	Historical
52959-221-20	52959022120	20 in 1 BOTTLE, PLASTIC	Historical
52959-221-30	52959022130	30 in 1 BOTTLE, PLASTIC	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dicyclomine	H.J. Harkins Company, Inc. \| West-ward Pharmaceutical Corp	2012-02-02	HUMAN PRESCRIPTION DRUG LABEL	1