dicyclomine hydrochloride

Product NDC: 0603-1161
11-digit product format: 006031161
Labeler code: 0603
Product ID: 0603-1161_fc9f1cd7-9096-40ae-99d3-c001d69fe165
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: dicyclomine hydrochloride
Dosage form: SOLUTION
Route: ORAL
Labeler: Par Health USA, LLC
Application: ANDA040169
Marketing category: ANDA
Marketing start: 2005-06-23
Substance: DICYCLOMINE HYDROCHLORIDE
Active strength: 10 mg/5mL
Pharmacologic classes: Anticholinergic [EPC], Cholinergic Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
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
A040169-001	DICYCLOMINE HYDROCHLORIDE	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040169-001	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.

Product history page 1 of 2 · 42 observed 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
2026-08-18 06:07:40	2026-07	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL		RS	2005-03-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL		RS	2005-03-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL		RS	2005-03-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL		RS	2005-03-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040169-001	DICYCLOMINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA	RS	2005-03-24	`e64feba35796…`

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	A040169-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040169-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040169-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040169-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040169-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040169-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040169-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040169-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040169-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040169-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040169-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040169-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040169-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040169-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040169-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040169-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040169-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040169-001	AA	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A040169-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040169-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040169-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040169-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040169-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040169-001	AA	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040169-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040169-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040169-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040169-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040169-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040169-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040169-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040169-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040169-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040169-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040169-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040169-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040169-001	AA	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A040169-001	AA	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: dicyclomine hydrochloride
Listing expiration: 2027-12-31

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
bb099db9-f635-4a64-8892-6236971dec45	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
0603-1161-58	dicyclomine hydrochloride	473 mL in 1 BOTTLE, PLASTIC	SOLUTION	473		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0603-1161-58	ML - Milliliter	0603-1161	7fbcc101-d82d-4199-9244-8993e2233eea	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DICYCLOMINE HYDROCHLORIDE	ACTIVE INGREDIENT	CQ903KQA31	DICYCLOMINE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS]	2
DICYCLOMINE HYDROCHLORIDE	ACTIVE INGREDIENT	CQ903KQA31	DICYCLOMINE HYDROCHLORIDE SOLUTION [QUALITEST PHARMACEUTICALS]	2
DICYCLOMINE	ACTIVE MOIETY	4KV4X8IF6V	DICYCLOMINE HYDROCHLORIDE SOLUTION [QUALITEST PHARMACEUTICALS]	2
DICYCLOMINE	ACTIVE MOIETY	4KV4X8IF6V	DICYCLOMINE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS]	2
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	DICYCLOMINE HYDROCHLORIDE SOLUTION [QUALITEST PHARMACEUTICALS]	2
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	DICYCLOMINE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DICYCLOMINE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DICYCLOMINE HYDROCHLORIDE SOLUTION [QUALITEST PHARMACEUTICALS]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	DICYCLOMINE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	DICYCLOMINE HYDROCHLORIDE SOLUTION [QUALITEST PHARMACEUTICALS]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	DICYCLOMINE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	DICYCLOMINE HYDROCHLORIDE SOLUTION [QUALITEST PHARMACEUTICALS]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	DICYCLOMINE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	DICYCLOMINE HYDROCHLORIDE SOLUTION [QUALITEST PHARMACEUTICALS]	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	DICYCLOMINE HYDROCHLORIDE SOLUTION [QUALITEST PHARMACEUTICALS]	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	DICYCLOMINE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	DICYCLOMINE HYDROCHLORIDE SOLUTION [QUALITEST PHARMACEUTICALS]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	DICYCLOMINE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS]	2
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	DICYCLOMINE HYDROCHLORIDE SOLUTION [QUALITEST PHARMACEUTICALS]	2
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	DICYCLOMINE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS]	2
SORBITOL	INACTIVE INGREDIENT	506T60A25R	DICYCLOMINE HYDROCHLORIDE SOLUTION [QUALITEST PHARMACEUTICALS]	2
SORBITOL	INACTIVE INGREDIENT	506T60A25R	DICYCLOMINE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS]	2
SUCROSE	INACTIVE INGREDIENT	C151H8M554	DICYCLOMINE HYDROCHLORIDE SOLUTION [QUALITEST PHARMACEUTICALS]	2
SUCROSE	INACTIVE INGREDIENT	C151H8M554	DICYCLOMINE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	DICYCLOMINE HYDROCHLORIDE SOLUTION [QUALITEST PHARMACEUTICALS]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	DICYCLOMINE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0603-1161	DICYCLOMINE HYDROCHLORIDE SOLUTION [ENDO USA, INC.]	7	Current NDC, Legacy NDC, 1 package rows	20250321_bb099db9-f635-4a64-8892-6236971dec45.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	Par Health USA, LLC	bb099db9-f635-4a64-8892-6236971dec45	2026-05-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040169 application number: ANDA040169 ndc (product): 0603-1161

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	bb099db9-f635-4a64-8892-6236971dec45	8
991082	dicyclomine hydrochloride 2 MG/ML Oral Solution	SCD	bb099db9-f635-4a64-8892-6236971dec45	8
991082	dicyclomine HCl 10 MG per 5 ML Oral Solution	SY	bb099db9-f635-4a64-8892-6236971dec45	8
991082	dicyclomine HCl 10 MG in 5 mL Oral Solution	PSN	95a0f538-4c94-487a-b85f-424eddd59459	3
991082	dicyclomine hydrochloride 2 MG/ML Oral Solution	SCD	95a0f538-4c94-487a-b85f-424eddd59459	3
991082	dicyclomine HCl 10 MG per 5 ML Oral Solution	SY	95a0f538-4c94-487a-b85f-424eddd59459	3
991082	dicyclomine HCl 10 MG in 5 mL Oral Solution	PSN	da753e89-d5ec-4183-920b-aa1c4e8c2197	2
991082	dicyclomine hydrochloride 2 MG/ML Oral Solution	SCD	da753e89-d5ec-4183-920b-aa1c4e8c2197	2
991082	dicyclomine HCl 10 MG per 5 ML Oral Solution	SY	da753e89-d5ec-4183-920b-aa1c4e8c2197	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0603-1161-58	00603116158	473 mL in 1 BOTTLE, PLASTIC (0603-1161-58)	473 ml	2005-06-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
dicyclomine hydrochloride	Par Health USA, LLC	2026-05-08	HUMAN PRESCRIPTION DRUG LABEL	8
dicyclomine hydrochloride	Bryant Ranch Prepack	2024-01-10	HUMAN PRESCRIPTION DRUG LABEL	102
dicyclomine hydrochloride	Carilion Materials Management	2017-12-28	HUMAN PRESCRIPTION DRUG LABEL	2
dicyclomine hydrochloride - Atlantic Biologicals Corps	Atlantic Biologicals Corps	2016-08-29	HUMAN PRESCRIPTION DRUG LABEL	3