Diphenhydramine HCl and Ibuprofen

Product NDC: 58602-717
11-digit product format: 586020717
Labeler code: 58602
Product ID: 58602-717_39af6dfa-e822-43a5-bd1a-338cf5da89ce
Type: HUMAN OTC DRUG
Nonproprietary name: Diphenhydramine HCl and Ibuprofen
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: Aurohealth LLC
Application: ANDA210676
Marketing category: ANDA
Marketing start: 2022-12-09
Substance: DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN
Active strength: 25; 200 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: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A210676-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL			2019-02-14

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A210676-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2019-02-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210676-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2019-02-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210676-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2019-02-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210676-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2019-02-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210676-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2019-02-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210676-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2019-02-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210676-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2019-02-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210676-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2019-02-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210676-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2019-02-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210676-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2019-02-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210676-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2019-02-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210676-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2019-02-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210676-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2019-02-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210676-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2019-02-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210676-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2019-02-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210676-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2019-02-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210676-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2019-02-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210676-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2019-02-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210676-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2019-02-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210676-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2019-02-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210676-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2019-02-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210676-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2019-02-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210676-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2019-02-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210676-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2019-02-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210676-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2019-02-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210676-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2019-02-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210676-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2019-02-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210676-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2019-02-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210676-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2019-02-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210676-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2019-02-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210676-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2019-02-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210676-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2019-02-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210676-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2019-02-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210676-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2019-02-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210676-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2019-02-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210676-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2019-02-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210676-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2019-02-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210676-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2019-02-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210676-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2019-02-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210676-001	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2019-02-14	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Diphenhydramine HCl and Ibuprofen
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIPHENHYDRAMINE HYDROCHLORIDE	25 mg/1
IBUPROFEN	200 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
TC2D6JAD40	Internal UNII lookup
WK2XYI10QM	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
901814	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
39af6dfa-e822-43a5-bd1a-338cf5da89ce	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
1e73f975-1ce7-705e-2bcf-788b1b5e24ba	Product name	5	20251124
0e2e0f88-b076-afe1-4bdd-32bca4375bec	Product name	3	20250127
16cde546-8deb-4df2-a072-dab5566ede95	Product name	1	20231003
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
f6d1b8d7-3bd1-4248-eddd-b60565c88015	Product name	4	20230808
874f4e63-49d2-5150-5d77-052172814ebd	Product name	6	20230105
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
557673c2-8256-b351-e863-4ec71a5a64b0	Product name	2	20160714
dbc9a339-6215-4e94-9546-57a3b34902ce	Product name	1	20160517
3e48c9c4-918d-5d23-2f0b-d2398b06be54	Product name	1	20140508
61c18d4e-b552-5478-8fc0-df38b93e3100	Product name	1	20140508
7b2938c9-7eb7-e312-ae90-f54f4240361e	Product name	1	20140508
865c72dd-0d94-daac-f728-ddd4ded2a79e	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
997601aa-bb5f-6971-6b90-a21132c12c7b	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58602-717-30	Diphenhydramine HCl and Ibuprofen	160 in 1 BOTTLE	CAPSULE, LIQUID FILLED	160		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58602-717	DIPHENHYDRAMINE HCL AND IBUPROFEN CAPSULE, LIQUID FILLED [AUROHEALTH LLC]	1	Current NDC, Legacy NDC, 1 package rows	20221210_39af6dfa-e822-43a5-bd1a-338cf5da89ce.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diphenhydramine HCl and Ibuprofen	DIPHENHYDRAMINE HCL AND IBUPROFEN	Aurohealth LLC	39af6dfa-e822-43a5-bd1a-338cf5da89ce	2022-12-09	Warnings	Exact identifier application applno (ANDA): 210676 application number: ANDA210676 ndc (product): 58602-717
Diphenhydramine HCl and Ibuprofen	DIPHENHYDRAMINE HCL AND IBUPROFEN	Aurohealth LLC	2c7c5349-06c9-401a-88e9-8f91ddb7f91a	2022-08-19	Warnings	Exact identifier application applno (ANDA): 210676 application number: ANDA210676
Diphenhydramine HCl and Ibuprofen	DIPHENHYDRAMINE HCL AND IBUPROFEN	Aurohealth LLC	a656f8b0-8cb4-4802-b8d3-7b95c0265d56	2022-02-21	Warnings	Exact identifier application applno (ANDA): 210676 application number: ANDA210676

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
901814	ibuprofen 200 MG / diphenhydrAMINE HCl 25 MG Oral Capsule	PSN	39af6dfa-e822-43a5-bd1a-338cf5da89ce	1
901814	diphenhydramine hydrochloride 25 MG / ibuprofen 200 MG Oral Capsule	SCD	39af6dfa-e822-43a5-bd1a-338cf5da89ce	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
58602-717-30	58602071730	160 CAPSULE, LIQUID FILLED in 1 BOTTLE (58602-717-30)	2022-12-09	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Diphenhydramine HCL and Ibuprofen Capsules USP 25 mg/200 mg	Aurohealth LLC \| APL HEALTHCARE LIMITED \| Aurobindo Pharma Limited	2022-12-09	Human OTC Drug Label	1