IBUPROFEN AND DIPHENHYDRAMINE HCL

Product NDC: 64380-732
Requested package NDC: 64380-732-12
11-digit product format: 643800732
Labeler code: 64380
Product ID: 64380-732_2c462426-b635-44dd-b4cb-54f67afb37d9
Type: HUMAN OTC DRUG
Nonproprietary name: IBUPROFEN AND DIPHENHYDRAMINE HCL
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: Strides Pharma Science Limited
Application: ANDA200888
Marketing category: ANDA
Marketing start: 2012-03-05
Marketing end: 0000-00-00
Substance: DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN
Active strength: 25 mg/1; mg/1
Pharmacologic classes: Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	64380-732	64380-732-12	D	Discontinued by firm		2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64380-732	64380-732-12	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64380-732	64380-732-12	D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

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
A200888-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL			2012-03-05

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A200888-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2012-03-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200888-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2012-03-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200888-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2012-03-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200888-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2012-03-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200888-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2012-03-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200888-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2012-03-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200888-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2012-03-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200888-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2012-03-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200888-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2012-03-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200888-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2012-03-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200888-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2012-03-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200888-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2012-03-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200888-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2012-03-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200888-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2012-03-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200888-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2012-03-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200888-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2012-03-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200888-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2012-03-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200888-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2012-03-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200888-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2012-03-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200888-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2012-03-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200888-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2012-03-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A200888-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2012-03-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A200888-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2012-03-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A200888-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2012-03-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A200888-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2012-03-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200888-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2012-03-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200888-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2012-03-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200888-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2012-03-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A200888-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2012-03-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A200888-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2012-03-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A200888-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2012-03-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A200888-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2012-03-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A200888-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2012-03-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A200888-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2012-03-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A200888-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2012-03-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A200888-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2012-03-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A200888-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2012-03-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A200888-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2012-03-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A200888-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2012-03-05	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A200888-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2012-03-05	`cb3db0bc1861…`

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DIPHENHYDRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	IBUPROFEN AND DIPHENHYDRAMINE HCL CAPSULE, LIQUID FILLED [STRIDES ARCOLAB LIMITED]	2
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	IBUPROFEN AND DIPHENHYDRAMINE HCL CAPSULE, LIQUID FILLED [STRIDES ARCOLAB LIMITED]	2
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	IBUPROFEN AND DIPHENHYDRAMINE HCL CAPSULE, LIQUID FILLED [STRIDES ARCOLAB LIMITED]	2
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	IBUPROFEN AND DIPHENHYDRAMINE HCL CAPSULE, LIQUID FILLED [STRIDES ARCOLAB LIMITED]	2
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	IBUPROFEN AND DIPHENHYDRAMINE HCL CAPSULE, LIQUID FILLED [STRIDES ARCOLAB LIMITED]	2
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	IBUPROFEN AND DIPHENHYDRAMINE HCL CAPSULE, LIQUID FILLED [STRIDES ARCOLAB LIMITED]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	IBUPROFEN AND DIPHENHYDRAMINE HCL CAPSULE, LIQUID FILLED [STRIDES ARCOLAB LIMITED]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	IBUPROFEN AND DIPHENHYDRAMINE HCL CAPSULE, LIQUID FILLED [STRIDES ARCOLAB LIMITED]	2
LECITHIN, SOYBEAN	INACTIVE INGREDIENT	1DI56QDM62	IBUPROFEN AND DIPHENHYDRAMINE HCL CAPSULE, LIQUID FILLED [STRIDES ARCOLAB LIMITED]	2
MEDIUM-CHAIN TRIGLYCERIDES	INACTIVE INGREDIENT	C9H2L21V7U	IBUPROFEN AND DIPHENHYDRAMINE HCL CAPSULE, LIQUID FILLED [STRIDES ARCOLAB LIMITED]	2
POLYETHYLENE GLYCOL 600	INACTIVE INGREDIENT	NL4J9F21N9	IBUPROFEN AND DIPHENHYDRAMINE HCL CAPSULE, LIQUID FILLED [STRIDES ARCOLAB LIMITED]	2
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	IBUPROFEN AND DIPHENHYDRAMINE HCL CAPSULE, LIQUID FILLED [STRIDES ARCOLAB LIMITED]	2
SHELLAC	INACTIVE INGREDIENT	46N107B71O	IBUPROFEN AND DIPHENHYDRAMINE HCL CAPSULE, LIQUID FILLED [STRIDES ARCOLAB LIMITED]	2
SORBITAN	INACTIVE INGREDIENT	6O92ICV9RU	IBUPROFEN AND DIPHENHYDRAMINE HCL CAPSULE, LIQUID FILLED [STRIDES ARCOLAB LIMITED]	2
SORBITOL	INACTIVE INGREDIENT	506T60A25R	IBUPROFEN AND DIPHENHYDRAMINE HCL CAPSULE, LIQUID FILLED [STRIDES ARCOLAB LIMITED]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	IBUPROFEN AND DIPHENHYDRAMINE HCL CAPSULE, LIQUID FILLED [STRIDES ARCOLAB LIMITED]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	IBUPROFEN AND DIPHENHYDRAMINE HCL CAPSULE, LIQUID FILLED [STRIDES ARCOLAB LIMITED]	2

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
Ibuprofen PM	IBUPROFEN, DIPHENHYDRAMINE HCL	TOP CARE (Topco Associates LLC)	7af82ca5-ea36-4b72-88b8-0fe68348d269	2026-05-19	Warnings	Exact identifier application applno (ANDA): 200888 application number: ANDA200888

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
TC2D6JAD40	DIPHENHYDRAMINE HYDROCHLORIDE	147-24-0	DIPHENHYDRAMINE HYDROCHLORIDE
WK2XYI10QM	IBUPROFEN	15687-27-1	IBUPROFEN

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
64380-732-12	64380073212	1 BOTTLE, PLASTIC in 1 CARTON (64380-732-12) > 40 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC	2016-12-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
IBUPROFEN AND DIPHENHYDRAMINE HCL 200 mg/25 mg	Strides Pharma Science Limited	2022-02-08	HUMAN OTC DRUG LABEL	8