Dicyclomine Hydrochloride

Product NDC: 0054-0622
11-digit product format: 000540622
Labeler code: 0054
Product ID: 0054-0622_8ad8c412-22d6-424f-9a52-48074ab28d4f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dicyclomine Hydrochloride
Dosage form: SOLUTION
Route: ORAL
Labeler: Hikma Pharmaceuticals USA Inc.
Application: ANDA212286
Marketing category: ANDA
Marketing start: 2020-05-22
Substance: DICYCLOMINE HYDROCHLORIDE
Active strength: 10 mg/5mL
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 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
A212286-001	DICYCLOMINE HYDROCHLORIDE	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA		2020-05-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212286-001	AA

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
2026-08-18 06:07:40	2026-07	A212286-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2020-05-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212286-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2020-05-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212286-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2020-05-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212286-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2020-05-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212286-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2020-05-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212286-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2020-05-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212286-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2020-05-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212286-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2020-05-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212286-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2020-05-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212286-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2020-05-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212286-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2020-05-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212286-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2020-05-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212286-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2020-05-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212286-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2020-05-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212286-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2020-05-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212286-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2020-05-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212286-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2020-05-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212286-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2020-05-22	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212286-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2020-05-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212286-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2020-05-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212286-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2020-05-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212286-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2020-05-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212286-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2020-05-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212286-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2020-05-22	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212286-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2020-05-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212286-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2020-05-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212286-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2020-05-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212286-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2020-05-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212286-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2020-05-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212286-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2020-05-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212286-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2020-05-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212286-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2020-05-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212286-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2020-05-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212286-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2020-05-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212286-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2020-05-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212286-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2020-05-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212286-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2020-05-22	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212286-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	2020-05-22	`a50c72e98297…`

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	A212286-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212286-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212286-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212286-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212286-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212286-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212286-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212286-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212286-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212286-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212286-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212286-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212286-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212286-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212286-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212286-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212286-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212286-001	AA	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212286-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212286-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212286-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212286-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212286-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212286-001	AA	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212286-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212286-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212286-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212286-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212286-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212286-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212286-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212286-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212286-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212286-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212286-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212286-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212286-001	AA	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212286-001	AA	1	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2020-12-22 03:56 UTC	2020-12	A212286-001	CGT	2020-11-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212286-001	CGT	2020-11-18	`c0c555d07b60…`

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	10 mg/5mL

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
991082	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
aa5bd79d-7f18-4032-8862-0c5429b2ecaf	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
0054-0622-63	Dicyclomine Hydrochloride	473 mL in 1 BOTTLE	SOLUTION	473		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0054-0622-63	ML - Milliliter	0054-0622	a479c7fe-0cb1-4f16-8ddf-a02da5782a9c	1	2020-06-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0054-0622	DICYCLOMINE HYDROCHLORIDE SOLUTION [HIKMA PHARMACEUTICALS USA INC.]	2	Current NDC, Legacy NDC, 1 package rows	20230513_aa5bd79d-7f18-4032-8862-0c5429b2ecaf.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 · 1 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.	aa5bd79d-7f18-4032-8862-0c5429b2ecaf	2023-01-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212286 application number: ANDA212286 ndc (product): 0054-0622

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
991082	dicyclomine HCl 10 MG in 5 mL Oral Solution	PSN	7b466007-2be7-4f1d-a41b-f71c0c90b69e	4
991082	dicyclomine hydrochloride 2 MG/ML Oral Solution	SCD	7b466007-2be7-4f1d-a41b-f71c0c90b69e	4
991082	dicyclomine HCl 10 MG per 5 ML Oral Solution	SY	7b466007-2be7-4f1d-a41b-f71c0c90b69e	4
991082	dicyclomine HCl 10 MG in 5 mL Oral Solution	PSN	aa5bd79d-7f18-4032-8862-0c5429b2ecaf	2
991082	dicyclomine hydrochloride 2 MG/ML Oral Solution	SCD	aa5bd79d-7f18-4032-8862-0c5429b2ecaf	2
991082	dicyclomine HCl 10 MG per 5 ML Oral Solution	SY	aa5bd79d-7f18-4032-8862-0c5429b2ecaf	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0054-0622-63	00054062263	473 mL in 1 BOTTLE (0054-0622-63)	473 ml	2020-05-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dicyclomine Hydrochloride	ATLANTIC BIOLOGICALS CORP.	2024-04-17	HUMAN PRESCRIPTION DRUG LABEL	4
Dicyclomine Hydrochloride	REMEDYREPACK INC.	2023-09-28	HUMAN PRESCRIPTION DRUG LABEL	3
Dicyclomine Hydrochloride	Hikma Pharmaceuticals USA Inc. \| West-Ward Columbus Inc.	2023-01-31	HUMAN PRESCRIPTION DRUG LABEL	2