Dicyclomine Hydrochloride

Product NDC: 69452-311
Requested package NDC: 69452-311-32
11-digit product format: 694520311
Labeler code: 69452
Product ID: 69452-311_1927b1f0-6fee-f127-e063-6394a90a05a3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dicyclomine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Bionpharma Inc.
Application: ANDA217916
Marketing category: ANDA
Marketing start: 2023-09-13
Substance: DICYCLOMINE HYDROCHLORIDE
Active strength: 20 mg/1
Pharmacologic classes: Anticholinergic [EPC], Cholinergic Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A217916-001	DICYCLOMINE HYDROCHLORIDE	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB		2023-08-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A217916-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A217916-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2023-08-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217916-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2023-08-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217916-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2023-08-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217916-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2023-08-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217916-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2023-08-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217916-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2023-08-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217916-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2023-08-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217916-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2023-08-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217916-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2023-08-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217916-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2023-08-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217916-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2023-08-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217916-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2023-08-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217916-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2023-08-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217916-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2023-08-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217916-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2023-08-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217916-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2023-08-04	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217916-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2023-08-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A217916-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2023-08-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A217916-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2023-08-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217916-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2023-08-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A217916-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2023-08-04	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217916-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2023-08-04	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A217916-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217916-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217916-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217916-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217916-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217916-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217916-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217916-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217916-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217916-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217916-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217916-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217916-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217916-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217916-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217916-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217916-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A217916-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A217916-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217916-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A217916-001	AB	1	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217916-001	AB	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Dicyclomine Hydrochloride
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DICYCLOMINE HYDROCHLORIDE	20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
CQ903KQA31	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
991086	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
051bfee3-06cf-309a-e063-6394a90a0bb3	Available on FDA.report

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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69452-311-20	Dicyclomine Hydrochloride	100 in 1 BOTTLE, PLASTIC	TABLET	100		2
69452-311-32	Dicyclomine Hydrochloride	1000 in 1 BOTTLE, PLASTIC	TABLET	1000		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69452-311-32	EA - Each	69452-311	f4f5bd36-054a-4570-ac73-3cd84836bc0d	1	2024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69452-311	DICYCLOMINE HYDROCHLORIDE TABLET [BIONPHARMA INC.]	2	Current NDC, 2 package rows	20240525_051bfee3-06cf-309a-e063-6394a90a0bb3.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Northwind Health Company, LLC	4dddbff3-2531-b35e-e063-6294a90a1d3b	2026-03-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217916 application number: ANDA217916
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	A-S Medication Solutions	2b33ef28-2b71-46c4-bb2f-694fefcd59ab	2026-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217916 application number: ANDA217916
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	3ee013cc-ab23-40a1-a44d-1d027c63b132	2026-01-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217916 application number: ANDA217916
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Bryant Ranch Prepack	8561b68a-c88b-4047-9fcf-2df7344543b2	2025-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217916 application number: ANDA217916
Dicyclomine Hydrochloride	DICYCLOMINE HYDROCHLORIDE	Bionpharma Inc.	051bfee3-06cf-309a-e063-6394a90a0bb3	2024-05-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217916 application number: ANDA217916 ndc (package): 69452-311-32 ndc (product): 69452-311 ndc11 (package): 69452031132

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	3ee013cc-ab23-40a1-a44d-1d027c63b132	4
991086	dicyclomine hydrochloride 20 MG Oral Tablet	SCD	3ee013cc-ab23-40a1-a44d-1d027c63b132	4
991086	dicyclomine HCl 20 MG Oral Tablet	PSN	051bfee3-06cf-309a-e063-6394a90a0bb3	2
991086	dicyclomine HCl 20 MG Oral Tablet	PSN	8561b68a-c88b-4047-9fcf-2df7344543b2	2
991086	dicyclomine hydrochloride 20 MG Oral Tablet	SCD	051bfee3-06cf-309a-e063-6394a90a0bb3	2
991086	dicyclomine hydrochloride 20 MG Oral Tablet	SCD	8561b68a-c88b-4047-9fcf-2df7344543b2	2
991086	dicyclomine HCl 20 MG Oral Tablet	PSN	2b33ef28-2b71-46c4-bb2f-694fefcd59ab	1
991086	dicyclomine HCl 20 MG Oral Tablet	PSN	4dddbff3-2531-b35e-e063-6294a90a1d3b	1
991086	dicyclomine HCl 20 MG Oral Tablet	PSN	5198641d-bba1-b053-e063-6394a90a592b	1
991086	dicyclomine hydrochloride 20 MG Oral Tablet	SCD	2b33ef28-2b71-46c4-bb2f-694fefcd59ab	1
991086	dicyclomine hydrochloride 20 MG Oral Tablet	SCD	4dddbff3-2531-b35e-e063-6294a90a1d3b	1
991086	dicyclomine hydrochloride 20 MG Oral Tablet	SCD	5198641d-bba1-b053-e063-6394a90a592b	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
69452-311-32	69452031132	1000 TABLET in 1 BOTTLE, PLASTIC (69452-311-32)	1000 tablet	2024-05-23	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dicyclomine Hydrochloride	Bionpharma Inc. \| Redpharm Drug	2026-05-12	HUMAN PRESCRIPTION DRUG LABEL	1
Dicyclomine Hydrochloride	Northwind Health Company, LLC	2026-03-06	HUMAN PRESCRIPTION DRUG LABEL	1
Dicyclomine Hydrochloride	A-S Medication Solutions	2026-02-06	HUMAN PRESCRIPTION DRUG LABEL	1
Dicyclomine Hydrochloride	Preferred Pharmaceuticals Inc.	2026-01-19	HUMAN PRESCRIPTION DRUG LABEL	4
Dicyclomine Hydrochloride	Bryant Ranch Prepack	2025-02-10	HUMAN PRESCRIPTION DRUG LABEL	2
Dicyclomine Hydrochloride	Bionpharma Inc. \| OrBion Pharmaceuticals Private Limited	2024-05-23	HUMAN PRESCRIPTION DRUG LABEL	2