Dicyclomine Hydrochloride

Product NDC: 53002-3291
Requested package NDC: 53002-3291-1
11-digit product format: 530023291
Labeler code: 53002
Product ID: 53002-3291_d313385b-cb2c-4d61-834c-c05dbbacc783
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dicyclomine Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: RPK 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: No
Listing certified through: 2021-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	53002-3291	53002-3291-1	I	Inactivated by FDA		2026-08-11

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 · 9 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
f27796e1-d653-495b-932a-f51768e9be8a	Product name	2	20211021

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
53002-3291-1	2025-01-30	These highlights do not include all the information needed to use DICYCLOMINE HYDROCHLOLRIDE CAPSULES and DICYCLOMINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DICYCLOMINE HYDROCHLOLRIDE CAPSULES and DICYCLOMINE HYDROCHLORIDE TABLETS. DICYCLOMINE HYDROCHLOLRIDE capsules, for oral use DICYCLOMINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1950
53002-3291-2	2025-01-30	These highlights do not include all the information needed to use DICYCLOMINE HYDROCHLOLRIDE CAPSULES and DICYCLOMINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DICYCLOMINE HYDROCHLOLRIDE CAPSULES and DICYCLOMINE HYDROCHLORIDE TABLETS. DICYCLOMINE HYDROCHLOLRIDE capsules, for oral use DICYCLOMINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1950
53002-3291-3	2025-01-30	These highlights do not include all the information needed to use DICYCLOMINE HYDROCHLOLRIDE CAPSULES and DICYCLOMINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DICYCLOMINE HYDROCHLOLRIDE CAPSULES and DICYCLOMINE HYDROCHLORIDE TABLETS. DICYCLOMINE HYDROCHLOLRIDE capsules, for oral use DICYCLOMINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1950
53002-3291-1	2023-06-08	These highlights do not include all the information needed to use DICYCLOMINE HYDROCHLOLRIDE CAPSULES and DICYCLOMINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DICYCLOMINE HYDROCHLOLRIDE CAPSULES and DICYCLOMINE HYDROCHLORIDE TABLETS. DICYCLOMINE HYDROCHLOLRIDE capsules, for oral use DICYCLOMINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1950
53002-3291-2	2023-06-08	These highlights do not include all the information needed to use DICYCLOMINE HYDROCHLOLRIDE CAPSULES and DICYCLOMINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DICYCLOMINE HYDROCHLOLRIDE CAPSULES and DICYCLOMINE HYDROCHLORIDE TABLETS. DICYCLOMINE HYDROCHLOLRIDE capsules, for oral use DICYCLOMINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1950
53002-3291-3	2023-06-08	These highlights do not include all the information needed to use DICYCLOMINE HYDROCHLOLRIDE CAPSULES and DICYCLOMINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DICYCLOMINE HYDROCHLOLRIDE CAPSULES and DICYCLOMINE HYDROCHLORIDE TABLETS. DICYCLOMINE HYDROCHLOLRIDE capsules, for oral use DICYCLOMINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1950
53002-3291-1	2023-01-30	These highlights do not include all the information needed to use DICYCLOMINE HYDROCHLOLRIDE CAPSULES and DICYCLOMINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DICYCLOMINE HYDROCHLOLRIDE CAPSULES and DICYCLOMINE HYDROCHLORIDE TABLETS. DICYCLOMINE HYDROCHLOLRIDE capsules, for oral use DICYCLOMINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1950
53002-3291-2	2023-01-30	These highlights do not include all the information needed to use DICYCLOMINE HYDROCHLOLRIDE CAPSULES and DICYCLOMINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DICYCLOMINE HYDROCHLOLRIDE CAPSULES and DICYCLOMINE HYDROCHLORIDE TABLETS. DICYCLOMINE HYDROCHLOLRIDE capsules, for oral use DICYCLOMINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1950
53002-3291-3	2023-01-30	These highlights do not include all the information needed to use DICYCLOMINE HYDROCHLOLRIDE CAPSULES and DICYCLOMINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DICYCLOMINE HYDROCHLOLRIDE CAPSULES and DICYCLOMINE HYDROCHLORIDE TABLETS. DICYCLOMINE HYDROCHLOLRIDE capsules, for oral use DICYCLOMINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1950

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
53002-3291-1	Dicyclomine Hydrochloride	10 in 1 BOTTLE	CAPSULE	10	3
53002-3291-2	Dicyclomine Hydrochloride	20 in 1 BOTTLE	CAPSULE	20	3
53002-3291-3	Dicyclomine Hydrochloride	30 in 1 BOTTLE	CAPSULE	30	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53002-3291	DICYCLOMINE HYDROCHLORIDE CAPSULE [RPK PHARMACEUTICALS, INC.]	3	Legacy NDC, 3 package rows	20230609_21c94731-2e5a-44b2-8500-829d2d33c42d.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	21c94731-2e5a-44b2-8500-829d2d33c42d	3
991061	dicyclomine hydrochloride 10 MG Oral Capsule	SCD	21c94731-2e5a-44b2-8500-829d2d33c42d	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53002-3291-1	53002329101	10 CAPSULE in 1 BOTTLE (53002-3291-1)	10 capsule	2019-01-01	0000-00-00	No	No	Current