Dicyclomine hydrochloride

Product NDC: 71335-2226
11-digit product format: 713352226
Labeler code: 71335
Product ID: 71335-2226_f2ba56dd-bb4e-4d75-ba92-2e3899a313b1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dicyclomine hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA216736
Marketing category: ANDA
Marketing start: 2022-12-14
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A216736-001	DICYCLOMINE HYDROCHLORIDE	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB		2022-12-14
A216736-002	DICYCLOMINE HYDROCHLORIDE	DICYCLOMINE HYDROCHLORIDE	40MG	TABLET / ORAL		RS	2025-03-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A216736-001	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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A216736-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB		2022-12-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216736-002	DICYCLOMINE HYDROCHLORIDE	40MG	TABLET / ORAL		RS	2025-03-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216736-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB		2022-12-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216736-002	DICYCLOMINE HYDROCHLORIDE	40MG	TABLET / ORAL		RS	2025-03-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216736-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB		2022-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216736-002	DICYCLOMINE HYDROCHLORIDE	40MG	TABLET / ORAL		RS	2025-03-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216736-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB		2022-12-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216736-002	DICYCLOMINE HYDROCHLORIDE	40MG	TABLET / ORAL		RS	2025-03-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216736-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB		2022-12-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216736-002	DICYCLOMINE HYDROCHLORIDE	40MG	TABLET / ORAL		RS	2025-03-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216736-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB		2022-12-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216736-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB		2022-12-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216736-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB		2022-12-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216736-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB		2022-12-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216736-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB		2022-12-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216736-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB		2022-12-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216736-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB		2022-12-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216736-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB		2022-12-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216736-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB		2022-12-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216736-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB		2022-12-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216736-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB		2022-12-14	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216736-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB		2022-12-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216736-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB		2022-12-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216736-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB		2022-12-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216736-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB		2022-12-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216736-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB		2022-12-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216736-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB		2022-12-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A216736-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB		2022-12-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A216736-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB		2022-12-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A216736-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB		2022-12-14	`3bdfa0b2c4d7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216736-001	DICYCLOMINE HYDROCHLORIDE	20MG	TABLET / ORAL	AB		2022-12-14	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216736-002	DICYCLOMINE HYDROCHLORIDE	40MG	TABLET / ORAL		RS	2025-03-25	`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	A216736-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216736-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216736-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216736-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216736-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216736-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216736-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216736-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216736-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216736-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216736-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216736-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216736-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216736-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216736-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216736-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216736-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216736-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216736-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216736-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216736-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216736-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A216736-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A216736-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A216736-001	AB	1	`3bdfa0b2c4d7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216736-001	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
1f3f4e0e-c04d-4208-8549-2bacaf547176	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	SPL version
71335-2226-0	Dicyclomine hydrochloride	10 in 1 BOTTLE	TABLET	10	101
71335-2226-1	Dicyclomine hydrochloride	30 in 1 BOTTLE	TABLET	30	101
71335-2226-2	Dicyclomine hydrochloride	40 in 1 BOTTLE	TABLET	40	101
71335-2226-3	Dicyclomine hydrochloride	60 in 1 BOTTLE	TABLET	60	101
71335-2226-4	Dicyclomine hydrochloride	90 in 1 BOTTLE	TABLET	90	101
71335-2226-5	Dicyclomine hydrochloride	20 in 1 BOTTLE	TABLET	20	101
71335-2226-6	Dicyclomine hydrochloride	21 in 1 BOTTLE	TABLET	21	101
71335-2226-7	Dicyclomine hydrochloride	120 in 1 BOTTLE	TABLET	120	101
71335-2226-8	Dicyclomine hydrochloride	100 in 1 BOTTLE	TABLET	100	101
71335-2226-9	Dicyclomine hydrochloride	28 in 1 BOTTLE	TABLET	28	101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71335-2226	DICYCLOMINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]	100	Current NDC, 10 package rows	20230824_1f3f4e0e-c04d-4208-8549-2bacaf547176.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 · 9 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	41aed1c9-b32f-3694-e063-6394a90a29e4	2026-06-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216736 application number: ANDA216736
Dicyclomine hydrochloride	DICYCLOMINE HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	3c1e31d4-c8b5-459e-9ada-2f1bae7fa219	2026-02-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216736 application number: ANDA216736
Dicyclomine hydrochloride	DICYCLOMINE HYDROCHLORIDE	Advagen Pharma Ltd.,	b4331e24-58af-45fb-a25b-9eb8270f83f7	2026-02-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216736 application number: ANDA216736
Dicyclomine hydrochloride	DICYCLOMINE HYDROCHLORIDE	Northwind Health Company, LLC	1d9acff5-6e8c-58dd-e063-6394a90a38f2	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216736 application number: ANDA216736
Dicyclomine hydrochloride	DICYCLOMINE HYDROCHLORIDE	Redpharm Drug	3b0ae3ed-77ef-d0df-e063-6294a90a7d17	2025-12-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216736 application number: ANDA216736
Dicyclomine hydrochloride	DICYCLOMINE HYDROCHLORIDE	Redpharm Drug	3de47f8d-e265-3f40-e063-6394a90aa3b0	2025-12-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216736 application number: ANDA216736
Dicyclomine hydrochloride	DICYCLOMINE HYDROCHLORIDE	A-S Medication Solutions	3713ae82-f36d-4491-9978-3111599ceafb	2025-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216736 application number: ANDA216736
Dicyclomine hydrochloride	DICYCLOMINE HYDROCHLORIDE	Bryant Ranch Prepack	1f3f4e0e-c04d-4208-8549-2bacaf547176	2025-10-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216736 application number: ANDA216736 ndc (product): 71335-2226
Dicyclomine hydrochloride	DICYCLOMINE HYDROCHLORIDE	Trifluent Pharma, LLC	56282794-5874-4220-b25c-cea4b17d19aa	2025-09-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216736 application number: ANDA216736

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	1f3f4e0e-c04d-4208-8549-2bacaf547176	101
991086	dicyclomine hydrochloride 20 MG Oral Tablet	SCD	1f3f4e0e-c04d-4208-8549-2bacaf547176	101

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
71335-2226-0	71335222600	10 TABLET in 1 BOTTLE (71335-2226-0)	10 tablet	2023-08-23	No	No	Current
71335-2226-1	71335222601	30 TABLET in 1 BOTTLE (71335-2226-1)	30 tablet	2023-08-23	No	No	Current
71335-2226-2	71335222602	40 TABLET in 1 BOTTLE (71335-2226-2)	40 tablet	2023-08-23	No	No	Current
71335-2226-3	71335222603	60 TABLET in 1 BOTTLE (71335-2226-3)	60 tablet	2023-08-23	No	No	Current
71335-2226-4	71335222604	90 TABLET in 1 BOTTLE (71335-2226-4)	90 tablet	2023-08-23	No	No	Current
71335-2226-5	71335222605	20 TABLET in 1 BOTTLE (71335-2226-5)	20 tablet	2023-08-23	No	No	Current
71335-2226-6	71335222606	21 TABLET in 1 BOTTLE (71335-2226-6)	21 tablet	2023-08-23	No	No	Current
71335-2226-7	71335222607	120 TABLET in 1 BOTTLE (71335-2226-7)	120 tablet	2023-08-23	No	No	Current
71335-2226-8	71335222608	100 TABLET in 1 BOTTLE (71335-2226-8)	100 tablet	2023-08-23	No	No	Current
71335-2226-9	71335222609	28 TABLET in 1 BOTTLE (71335-2226-9)	28 tablet	2023-08-23	No	No	Current