Dicyclomine Hydrochloride

Product NDC: 0527-1282
11-digit product format: 005271282
Labeler code: 0527
Product ID: 0527-1282_2d14aa91-5d9d-42fe-b185-9c3bcd18a513
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dicyclomine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Lannett Company, Inc.
Application: ANDA040230
Marketing category: ANDA
Marketing start: 1999-02-26
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

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	20 mg/1

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	CQ903KQA31

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, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0527-1282-01	2024-01-30	C162847	48780-1	1030e365-1c7d-111a-e063-dadaa90a10e2	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
0527-1282-01	2024-01-30	C162847	48780-1	1030e365-1c7d-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use DICYCLOMINE HYDROCHLORIDE CAPSULES and DICYCLOMINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DICYCLOMINE HYDROCHLORIDE CAPSULES and DICYCLOMINE HYDROCHLORIDE TABLETS. DICYCLOMINE HYDROCHLORIDE capsules, for oral use DICYCLOMINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1950
0527-1282-05	2024-01-30	C162847	48780-1	1030e365-1c7d-111a-e063-dadaa90a10e2	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
0527-1282-05	2024-01-30	C162847	48780-1	1030e365-1c7d-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use DICYCLOMINE HYDROCHLORIDE CAPSULES and DICYCLOMINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DICYCLOMINE HYDROCHLORIDE CAPSULES and DICYCLOMINE HYDROCHLORIDE TABLETS. DICYCLOMINE HYDROCHLORIDE capsules, for oral use DICYCLOMINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1950
0527-1282-10	2024-01-30	C162847	48780-1	1030e365-1c7d-111a-e063-dadaa90a10e2	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
0527-1282-10	2024-01-30	C162847	48780-1	1030e365-1c7d-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use DICYCLOMINE HYDROCHLORIDE CAPSULES and DICYCLOMINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DICYCLOMINE HYDROCHLORIDE CAPSULES and DICYCLOMINE HYDROCHLORIDE TABLETS. DICYCLOMINE HYDROCHLORIDE 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
0527-1282-01	Dicyclomine Hydrochloride	100 in 1 BOTTLE	TABLET	100	21
0527-1282-05	Dicyclomine Hydrochloride	500 in 1 BOTTLE	TABLET	500	21
0527-1282-10	Dicyclomine Hydrochloride	1000 in 1 BOTTLE	TABLET	1000	21

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0527-1282-01	EA - Each	0527-1282	53e2ec24-a7b6-43b6-81c9-9457a1e2f7ce	1	2012-07-24
0527-1282-10	EA - Each	0527-1282	9c0f7d79-a338-47e2-8a74-8368cca3db30	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 TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [LANNETT COMPANY, INC.]	13
DICYCLOMINE	ACTIVE MOIETY	4KV4X8IF6V	DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [LANNETT COMPANY, INC.]	13
ACACIA	INACTIVE INGREDIENT	5C5403N26O	DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [LANNETT COMPANY, INC.]	13
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [LANNETT COMPANY, INC.]	13
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [LANNETT COMPANY, INC.]	13
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [LANNETT COMPANY, INC.]	13
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [LANNETT COMPANY, INC.]	13
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [LANNETT COMPANY, INC.]	13
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [LANNETT COMPANY, INC.]	13
CALCIUM SULFATE	INACTIVE INGREDIENT	WAT0DDB505	DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [LANNETT COMPANY, INC.]	13
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [LANNETT COMPANY, INC.]	13
FD&C RED NO. 3	INACTIVE INGREDIENT	PN2ZH5LOQY	DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [LANNETT COMPANY, INC.]	13
GELATIN	INACTIVE INGREDIENT	2G86QN327L	DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [LANNETT COMPANY, INC.]	13
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [LANNETT COMPANY, INC.]	13
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [LANNETT COMPANY, INC.]	13
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [LANNETT COMPANY, INC.]	13
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [LANNETT COMPANY, INC.]	13
SHELLAC	INACTIVE INGREDIENT	46N107B71O	DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [LANNETT COMPANY, INC.]	13
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [LANNETT COMPANY, INC.]	13
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [LANNETT COMPANY, INC.]	13
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [LANNETT COMPANY, INC.]	13
SUCROSE	INACTIVE INGREDIENT	C151H8M554	DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [LANNETT COMPANY, INC.]	13
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [LANNETT COMPANY, INC.]	13
Dicyclomine Hydrochloride	ACTIVE INGREDIENT	CQ903KQA31	DICYCLOMINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	2
Dicyclomine	ACTIVE MOIETY	4KV4X8IF6V	DICYCLOMINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	2
ACACIA	INACTIVE INGREDIENT	5C5403N26O	DICYCLOMINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	2
ANHYDROUS DIBASIC CALCIUM PHOSPHATE	INACTIVE INGREDIENT	L11K75P92J	DICYCLOMINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	2
anhydrous lactose	INACTIVE INGREDIENT	3SY5LH9PMK	DICYCLOMINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DICYCLOMINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	2
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	DICYCLOMINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DICYCLOMINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	DICYCLOMINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	2
stearic acid	INACTIVE INGREDIENT	4ELV7Z65AP	DICYCLOMINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	2
SUCROSE	INACTIVE INGREDIENT	C151H8M554	DICYCLOMINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	2
DICYCLOMINE HYDROCHLORIDE	ACTIVE INGREDIENT	CQ903KQA31	DICYCLOMINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	1
DICYCLOMINE HYDROCHLORIDE	ACTIVE INGREDIENT	CQ903KQA31	DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
DICYCLOMINE HYDROCHLORIDE	ACTIVE INGREDIENT	CQ903KQA31	DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]	1
DICYCLOMINE HYDROCHLORIDE	ACTIVE INGREDIENT	CQ903KQA31	DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
DICYCLOMINE	ACTIVE MOIETY	4KV4X8IF6V	DICYCLOMINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	1
DICYCLOMINE	ACTIVE MOIETY	4KV4X8IF6V	DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
DICYCLOMINE	ACTIVE MOIETY	4KV4X8IF6V	DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
DICYCLOMINE	ACTIVE MOIETY	4KV4X8IF6V	DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]	1
ACACIA	INACTIVE INGREDIENT	5C5403N26O	DICYCLOMINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	1
ACACIA	INACTIVE INGREDIENT	5C5403N26O	DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
ACACIA	INACTIVE INGREDIENT	5C5403N26O	DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]	1
ACACIA	INACTIVE INGREDIENT	5C5403N26O	DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	DICYCLOMINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	1
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]	1
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	DICYCLOMINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]	1
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]	1
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]	1
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	DICYCLOMINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	1
CALCIUM SULFATE	INACTIVE INGREDIENT	WAT0DDB505	DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
CALCIUM SULFATE	INACTIVE INGREDIENT	WAT0DDB505	DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]	1
CALCIUM SULFATE	INACTIVE INGREDIENT	WAT0DDB505	DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DICYCLOMINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
FD&C RED NO. 3	INACTIVE INGREDIENT	PN2ZH5LOQY	DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
FD&C RED NO. 3	INACTIVE INGREDIENT	PN2ZH5LOQY	DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]	1
FD&C RED NO. 3	INACTIVE INGREDIENT	PN2ZH5LOQY	DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]	1
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DICYCLOMINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DICYCLOMINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	DICYCLOMINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	DICYCLOMINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	DICYCLOMINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0527-1282	DICYCLOMINE HYDROCHLORIDE TABLET DICYCLOMINE HYDROCHLORIDE CAPSULE [LANNETT COMPANY, INC.]	21	Current NDC, Legacy NDC, 3 package rows	20240704_bd2cba10-70ec-4d1f-b46c-53d1de2ee130.zip

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	3dc0f4f0-ee38-4f9b-abb6-6395215fe524	100
991086	dicyclomine hydrochloride 20 MG Oral Tablet	SCD	3dc0f4f0-ee38-4f9b-abb6-6395215fe524	100
991061	dicyclomine HCl 10 MG Oral Capsule	PSN	b3c9dc85-2c6c-44f0-9c98-02673af934cb	24
991086	dicyclomine HCl 20 MG Oral Tablet	PSN	b3c9dc85-2c6c-44f0-9c98-02673af934cb	24
991061	dicyclomine hydrochloride 10 MG Oral Capsule	SCD	b3c9dc85-2c6c-44f0-9c98-02673af934cb	24
991086	dicyclomine hydrochloride 20 MG Oral Tablet	SCD	b3c9dc85-2c6c-44f0-9c98-02673af934cb	24
991061	dicyclomine HCl 10 MG Oral Capsule	PSN	bd2cba10-70ec-4d1f-b46c-53d1de2ee130	21
991086	dicyclomine HCl 20 MG Oral Tablet	PSN	bd2cba10-70ec-4d1f-b46c-53d1de2ee130	21
991061	dicyclomine hydrochloride 10 MG Oral Capsule	SCD	bd2cba10-70ec-4d1f-b46c-53d1de2ee130	21
991086	dicyclomine hydrochloride 20 MG Oral Tablet	SCD	bd2cba10-70ec-4d1f-b46c-53d1de2ee130	21
991086	dicyclomine HCl 20 MG Oral Tablet	PSN	7ff96d1f-fb87-4244-a697-1d93e10eb738	12
991086	dicyclomine hydrochloride 20 MG Oral Tablet	SCD	7ff96d1f-fb87-4244-a697-1d93e10eb738	12
991086	dicyclomine HCl 20 MG Oral Tablet	PSN	34db5a80-f445-41e5-b3c4-4c18abb09c92	10
991086	dicyclomine hydrochloride 20 MG Oral Tablet	SCD	34db5a80-f445-41e5-b3c4-4c18abb09c92	10
991061	dicyclomine HCl 10 MG Oral Capsule	PSN	3b7145d7-1ba7-45c1-8202-b8fc575d5a8e	7
991086	dicyclomine HCl 20 MG Oral Tablet	PSN	6fb9d156-f321-4f7d-b308-2a0e6056fd71	7
991086	dicyclomine HCl 20 MG Oral Tablet	PSN	3b7145d7-1ba7-45c1-8202-b8fc575d5a8e	7
991086	dicyclomine HCl 20 MG Oral Tablet	PSN	4e2d33d8-84ad-2abd-e054-00144ff88e88	7
991061	dicyclomine hydrochloride 10 MG Oral Capsule	SCD	3b7145d7-1ba7-45c1-8202-b8fc575d5a8e	7
991086	dicyclomine hydrochloride 20 MG Oral Tablet	SCD	3b7145d7-1ba7-45c1-8202-b8fc575d5a8e	7
991086	dicyclomine hydrochloride 20 MG Oral Tablet	SCD	6fb9d156-f321-4f7d-b308-2a0e6056fd71	7
991086	dicyclomine hydrochloride 20 MG Oral Tablet	SCD	4e2d33d8-84ad-2abd-e054-00144ff88e88	7
991061	dicyclomine HCl 10 MG Oral Capsule	PSN	5eee0dff-d157-4534-adfb-c035b7042c07	6
991061	dicyclomine HCl 10 MG Oral Capsule	PSN	833c5d7c-85ca-4ce3-bcd8-5e5b4ecbffe8	6
991086	dicyclomine HCl 20 MG Oral Tablet	PSN	5eee0dff-d157-4534-adfb-c035b7042c07	6
991086	dicyclomine HCl 20 MG Oral Tablet	PSN	833c5d7c-85ca-4ce3-bcd8-5e5b4ecbffe8	6
991061	dicyclomine hydrochloride 10 MG Oral Capsule	SCD	833c5d7c-85ca-4ce3-bcd8-5e5b4ecbffe8	6
991061	dicyclomine hydrochloride 10 MG Oral Capsule	SCD	5eee0dff-d157-4534-adfb-c035b7042c07	6
991086	dicyclomine hydrochloride 20 MG Oral Tablet	SCD	833c5d7c-85ca-4ce3-bcd8-5e5b4ecbffe8	6
991086	dicyclomine hydrochloride 20 MG Oral Tablet	SCD	5eee0dff-d157-4534-adfb-c035b7042c07	6
991086	dicyclomine HCl 20 MG Oral Tablet	PSN	82832a91-d16c-3a63-e053-2a91aa0a3ffb	5
991086	dicyclomine hydrochloride 20 MG Oral Tablet	SCD	82832a91-d16c-3a63-e053-2a91aa0a3ffb	5
991086	dicyclomine HCl 20 MG Oral Tablet	PSN	902948bc-fecd-5c56-e053-2995a90afb6e	3
991086	dicyclomine hydrochloride 20 MG Oral Tablet	SCD	902948bc-fecd-5c56-e053-2995a90afb6e	3
991086	dicyclomine HCl 20 MG Oral Tablet	PSN	dee66e82-be30-47a3-be50-14cbbb7ebc8a	2
991086	dicyclomine HCl 20 MG Oral Tablet	PSN	57ab6992-7b98-4503-b4bb-98d76ccf603e	2
991086	dicyclomine HCl 20 MG Oral Tablet	PSN	676078a3-13e5-cc32-e053-2a91aa0ac75f	2
991086	dicyclomine HCl 20 MG Oral Tablet	PSN	da82cb46-7b4b-1ef5-e053-2a95a90ad10d	2
991086	dicyclomine hydrochloride 20 MG Oral Tablet	SCD	da82cb46-7b4b-1ef5-e053-2a95a90ad10d	2
991086	dicyclomine hydrochloride 20 MG Oral Tablet	SCD	dee66e82-be30-47a3-be50-14cbbb7ebc8a	2
991086	dicyclomine hydrochloride 20 MG Oral Tablet	SCD	676078a3-13e5-cc32-e053-2a91aa0ac75f	2
991086	dicyclomine hydrochloride 20 MG Oral Tablet	SCD	57ab6992-7b98-4503-b4bb-98d76ccf603e	2
991061	dicyclomine HCl 10 MG Oral Capsule	PSN	d9daced1-c2e0-47c3-b590-c77f3da94e88	1
991086	dicyclomine HCl 20 MG Oral Tablet	PSN	0fecc9b6-076b-148b-e054-00144ff88e88	1
991086	dicyclomine HCl 20 MG Oral Tablet	PSN	ec94d19c-33d9-dc02-e053-2995a90a01be	1
991086	dicyclomine HCl 20 MG Oral Tablet	PSN	da2c43f8-1c3a-447f-8994-f9899fb5e141	1
991086	dicyclomine HCl 20 MG Oral Tablet	PSN	d9daced1-c2e0-47c3-b590-c77f3da94e88	1
991061	dicyclomine hydrochloride 10 MG Oral Capsule	SCD	d9daced1-c2e0-47c3-b590-c77f3da94e88	1
991086	dicyclomine hydrochloride 20 MG Oral Tablet	SCD	da2c43f8-1c3a-447f-8994-f9899fb5e141	1
991086	dicyclomine hydrochloride 20 MG Oral Tablet	SCD	d9daced1-c2e0-47c3-b590-c77f3da94e88	1
991086	dicyclomine hydrochloride 20 MG Oral Tablet	SCD	ec94d19c-33d9-dc02-e053-2995a90a01be	1
991086	dicyclomine hydrochloride 20 MG Oral Tablet	SCD	0fecc9b6-076b-148b-e054-00144ff88e88	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0527-1282-01	00527128201	100 TABLET in 1 BOTTLE (0527-1282-01)	100 tablet	1999-02-26	0000-00-00	No	No	Current
0527-1282-05	00527128205	500 TABLET in 1 BOTTLE (0527-1282-05)	500 tablet	1999-02-26	0000-00-00	No	No	Current
0527-1282-10	00527128210	1000 TABLET in 1 BOTTLE (0527-1282-10)	1000 tablet	1999-02-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dicyclomine Hydrochloride	Lannett Company, Inc.	2026-06-01	HUMAN PRESCRIPTION DRUG LABEL	22
Dicyclomine Hydrochloride	Preferred Pharmaceuticals Inc.	2026-04-06	HUMAN PRESCRIPTION DRUG LABEL	7
Dicyclomine Hydrochloride	REMEDYREPACK INC.	2026-01-28	HUMAN PRESCRIPTION DRUG LABEL	12
Dicyclomine Hydrochloride	Northwind Health Company, LLC	2026-01-01	HUMAN PRESCRIPTION DRUG LABEL	2
Dicyclomine Hydrochloride	Major Pharmaceuticals	2025-07-07	HUMAN PRESCRIPTION DRUG LABEL	6
Dicyclomine Hydrochloride	Proficient Rx LP	2025-06-01	HUMAN PRESCRIPTION DRUG LABEL	7
Dicyclomine Hydrochloride	NuCare Pharmaceuticals,Inc.	2024-09-12	HUMAN PRESCRIPTION DRUG LABEL	5
Dicyclomine Hydrochloride	American Health Packaging	2024-08-29	HUMAN PRESCRIPTION DRUG LABEL	6
Dicyclomine 20 mg Tablet	RedPharm Drug, Inc.	2024-07-11	HUMAN PRESCRIPTION DRUG LABEL	7
Dicyclomine Hydrochloride	A-S Medication Solutions	2024-02-09	HUMAN PRESCRIPTION DRUG LABEL	24
Dicyclomine Hydrochloride	Bryant Ranch Prepack	2023-10-19	HUMAN PRESCRIPTION DRUG LABEL	10
Dicyclomine Hydrochloride	Bryant Ranch Prepack	2023-05-08	HUMAN PRESCRIPTION DRUG LABEL	100
Dicyclomine Hydrochloride	RPK Pharmaceuticals, Inc.	2023-01-31	HUMAN PRESCRIPTION DRUG LABEL	2
Dicyclomine Hydrochloride	NuCare Pharmaceuticals,Inc.	2022-11-03	HUMAN PRESCRIPTION DRUG LABEL	1
DICYCLOMINE HYDROCHLORIDE	Direct_Rx	2021-01-12	HUMAN PRESCRIPTION DRUG LABEL	3
DICYCLOMINE HYDROCHLORIDE	DIRECT RX	2021-01-12	HUMAN PRESCRIPTION DRUG LABEL	2
Dicyclomine Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	2018-12-20	HUMAN PRESCRIPTION DRUG LABEL	1
Dicyclomine Hydrochloride	Blenheim Pharmacal, Inc.	2015-02-25	HUMAN PRESCRIPTION DRUG LABEL	1
Dicyclomine Hydrochloride	Aidarex Pharmaceuticals LLC	2013-12-27	HUMAN PRESCRIPTION DRUG LABEL	1
Dicyclomine Hydrochloride	Rebel Distributors Corp	2010-09-24	HUMAN PRESCRIPTION DRUG LABEL	2

Dicyclomine Hydrochloride

Additional Listing Data#

Related Records#

Active Ingredients#

Harmonized Identifiers#

DailyMed Product Concepts#

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#