Diphenoxylate Hydrochloride and Atropine Sulfate

Product NDC: 0054-3194
Requested package NDC: 0054-3194-46
11-digit product format: 000543194
Labeler code: 0054
Product ID: 0054-3194_92ce86bc-7f23-43ec-9374-a51bacef9461
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Diphenoxylate Hydrochloride and Atropine Sulfate
Dosage form: SOLUTION
Route: ORAL
Labeler: Hikma Pharmaceuticals USA Inc.
Application: ANDA087708
Marketing category: ANDA
Marketing start: 1982-05-03
Substance: ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE
Active strength: .025; 2.5 mg/5mL; mg/5mL
Pharmacologic classes: Anticholinergic [EPC], Antidiarrheal [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
DEA schedule: CV
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 1.

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
A087708-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE	0.025MG/5ML;2.5MG/5ML	SOLUTION / ORAL		RLD, RS	1982-05-03

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A087708-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RLD, RS	1982-05-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A087708-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RLD, RS	1982-05-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A087708-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RLD, RS	1982-05-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A087708-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RS	1982-05-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A087708-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RS	1982-05-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A087708-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RS	1982-05-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A087708-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RS	1982-05-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A087708-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RS	1982-05-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A087708-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RS	1982-05-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A087708-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RS	1982-05-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A087708-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RS	1982-05-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A087708-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RS	1982-05-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A087708-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RS	1982-05-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A087708-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RS	1982-05-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A087708-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RS	1982-05-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A087708-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RS	1982-05-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A087708-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RS	1982-05-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A087708-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RS	1982-05-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A087708-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RS	1982-05-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A087708-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RS	1982-05-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A087708-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RS	1982-05-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A087708-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RS	1982-05-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A087708-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RS	1982-05-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A087708-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RS	1982-05-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A087708-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RS	1982-05-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A087708-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RS	1982-05-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A087708-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RS	1982-05-03	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A087708-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RS	1982-05-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A087708-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RS	1982-05-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A087708-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RS	1982-05-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A087708-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RS	1982-05-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A087708-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RS	1982-05-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A087708-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RS	1982-05-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A087708-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RS	1982-05-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A087708-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RS	1982-05-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A087708-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RS	1982-05-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A087708-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RS	1982-05-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A087708-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RS	1982-05-03	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A087708-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RS	1982-05-03	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A087708-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG/5ML;2.5MG/5ML	SOLUTION / ORAL	RS	1982-05-03	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Diphenoxylate Hydrochloride and Atropine Sulfate
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIPHENOXYLATE HYDROCHLORIDE	.025 mg/5mL
ATROPINE SULFATE	2.5 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
W24OD7YW48	Internal UNII lookup
03J5ZE7KA5	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1190568	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
88ed4ccf-9e35-4142-a5eb-d2b5edd36956	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6c78bd43-efb4-4aeb-b7d8-eff1532f7822	Product name	4	20250801
41231c1e-8789-4da7-ac52-77fa90a85bf5	Product name	2	20250304
e77ab9a2-80cf-4832-bff0-469bbc7cbcd0	Product name	2	20250214
5f84b7a7-523a-f042-dffb-1dadcd9b2407	Product name	4	20240110
0cbc6fb2-78c0-4b88-98f0-a4cc76ff95ca	Product name	1	20230719
04cd5dc0-102f-46cb-8dbc-ca38dd2628d0	Product name	3	20230317
dfd25202-b8d2-4628-9213-f3e0f9eafce5	Product name	4	20210513
4199bf9b-4718-828a-6dd6-ac2fbbd61687	Product name	1	20140508
4edd8af5-cea7-ae42-8023-e91c5335db1d	Product name	1	20140508
d3908afb-7784-440f-c406-88294732d36a	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0054-3194-46	Diphenoxylate Hydrochloride and Atropine Sulfate	60 mL in 1 BOTTLE	SOLUTION	60		8
0054-3194-46	Diphenoxylate Hydrochloride and Atropine Sulfate	1 in 1 CARTON	SOLUTION	1		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0054-3194-46	ML - Milliliter	0054-3194	7a17f727-3f97-4c86-8c29-406cdc172fe6	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ATROPINE SULFATE	ACTIVE INGREDIENT	03J5ZE7KA5	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE SOLUTION [ROXANE LABORATORIES, INC]	3
DIPHENOXYLATE HYDROCHLORIDE	ACTIVE INGREDIENT	W24OD7YW48	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE SOLUTION [ROXANE LABORATORIES, INC]	3
ATROPINE	ACTIVE MOIETY	7C0697DR9I	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE SOLUTION [ROXANE LABORATORIES, INC]	3
DIPHENOXYLATE	ACTIVE MOIETY	73312P173G	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE SOLUTION [ROXANE LABORATORIES, INC]	3
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE SOLUTION [ROXANE LABORATORIES, INC]	3
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE SOLUTION [ROXANE LABORATORIES, INC]	3
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE SOLUTION [ROXANE LABORATORIES, INC]	3
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE SOLUTION [ROXANE LABORATORIES, INC]	3
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE SOLUTION [ROXANE LABORATORIES, INC]	3
MALTOL	INACTIVE INGREDIENT	3A9RD92BS4	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE SOLUTION [ROXANE LABORATORIES, INC]	3
POTASSIUM SORBATE	INACTIVE INGREDIENT	1VPU26JZZ4	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE SOLUTION [ROXANE LABORATORIES, INC]	3
SORBITOL	INACTIVE INGREDIENT	506T60A25R	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE SOLUTION [ROXANE LABORATORIES, INC]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE SOLUTION [ROXANE LABORATORIES, INC]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0054-3194	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE SOLUTION [HIKMA PHARMACEUTICALS USA INC.]	7	Current NDC, Legacy NDC, 2 package rows	20230502_88ed4ccf-9e35-4142-a5eb-d2b5edd36956.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
Diphenoxylate Hydrochloride and Atropine Sulfate	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	Hikma Pharmaceuticals USA Inc.	88ed4ccf-9e35-4142-a5eb-d2b5edd36956	2025-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087708 application number: ANDA087708 ndc (package): 0054-3194-46 ndc (product): 0054-3194 ndc11 (package): 00054319446

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
03J5ZE7KA5	ATROPINE SULFATE	5908-99-6	ATROPINE SULFATE
W24OD7YW48	DIPHENOXYLATE HYDROCHLORIDE	3810-80-8	DIPHENOXYLATE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1190568	atropine sulfate 0.025 MG / diphenoxylate HCl 2.5 MG in 5 mL Oral Solution	PSN	88ed4ccf-9e35-4142-a5eb-d2b5edd36956	8
1190568	atropine sulfate 0.005 MG/ML / diphenoxylate hydrochloride 0.5 MG/ML Oral Solution	SCD	88ed4ccf-9e35-4142-a5eb-d2b5edd36956	8
1190568	atropine sulfate 0.025 MG / diphenoxylate HCl 2.5 MG per 5 ML Oral Solution	SY	88ed4ccf-9e35-4142-a5eb-d2b5edd36956	8
1190568	atropine sulfate 0.025 MG / diphenoxylate HCl 2.5 MG in 5 mL Oral Solution	PSN	b0c91667-ab6f-481d-a592-62da8a52abf7	2
1190568	atropine sulfate 0.025 MG / diphenoxylate HCl 2.5 MG in 5 mL Oral Solution	PSN	cb933606-151e-4fa4-bebe-b11c1ec41100	2
1190568	atropine sulfate 0.005 MG/ML / diphenoxylate hydrochloride 0.5 MG/ML Oral Solution	SCD	b0c91667-ab6f-481d-a592-62da8a52abf7	2
1190568	atropine sulfate 0.005 MG/ML / diphenoxylate hydrochloride 0.5 MG/ML Oral Solution	SCD	cb933606-151e-4fa4-bebe-b11c1ec41100	2
1190568	atropine sulfate 0.025 MG / diphenoxylate HCl 2.5 MG per 5 ML Oral Solution	SY	b0c91667-ab6f-481d-a592-62da8a52abf7	2
1190568	atropine sulfate 0.025 MG / diphenoxylate HCl 2.5 MG per 5 ML Oral Solution	SY	cb933606-151e-4fa4-bebe-b11c1ec41100	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0054-3194-46	00054319446	1 BOTTLE in 1 CARTON (0054-3194-46) / 60 mL in 1 BOTTLE	1 bottle	1982-05-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Diphenoxylate Hydrochloride and Atropine Sulfate Oral Solution, USP for oral use, C-V Rx only	Hikma Pharmaceuticals USA Inc. \| West-Ward Columbus Inc.	2025-06-26	HUMAN PRESCRIPTION DRUG LABEL	9
Diphenoxylate Hydrochloride and Atropine Sulfate Oral Solution USP CV	Lohxa	2019-09-10	HUMAN PRESCRIPTION DRUG LABEL	2
Diphenoxylate Hydrochloride and Atropine Sulfate Oral Solution USP CV	Atlantic Biologicals Corps	2017-12-20	HUMAN PRESCRIPTION DRUG LABEL	2