FENOPROFEN CALCIUM

Product NDC: 69336-124
Requested package NDC: 69336-124-10
11-digit product format: 693360124
Labeler code: 69336
Product ID: 69336-124_81a0da5b-6078-413e-b6d0-d31c1073b3f7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: FENOPROFEN CALCIUM
Dosage form: CAPSULE
Route: ORAL
Labeler: Sterling Knight Pharmaceuticals
Application: NDA017604
Marketing category: NDA
Marketing start: 2016-07-06
Marketing end: 0000-00-00
Substance: FENOPROFEN CALCIUM
Active strength: 200 mg/1
Pharmacologic classes: Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag: No
Listing certified through: 2021-12-31
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	69336-124	69336-124-10	I	Inactivated by FDA		2026-08-10

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 · 18 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	`bd6a592717d7…`	`303034d00443…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N017604-002	NALFON	FENOPROFEN CALCIUM	EQ 300MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	Approved before 1982
N017604-003	NALFON	FENOPROFEN CALCIUM	EQ 200MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982
N017604-004	NALFON	FENOPROFEN CALCIUM	EQ 400MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2009-07-21

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 4 · 123 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	N017604-002	NALFON	EQ 300MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017604-003	NALFON	EQ 200MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017604-004	NALFON	EQ 400MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2009-07-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017604-002	NALFON	EQ 300MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017604-003	NALFON	EQ 200MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017604-004	NALFON	EQ 400MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2009-07-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017604-002	NALFON	EQ 300MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017604-003	NALFON	EQ 200MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017604-004	NALFON	EQ 400MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2009-07-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017604-002	NALFON	EQ 300MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017604-003	NALFON	EQ 200MG BASE	CAPSULE / ORAL	RLD, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017604-004	NALFON	EQ 400MG BASE	CAPSULE / ORAL	RLD	2009-07-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017604-002	NALFON	EQ 300MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017604-003	NALFON	EQ 200MG BASE	CAPSULE / ORAL	RLD, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017604-004	NALFON	EQ 400MG BASE	CAPSULE / ORAL	RLD	2009-07-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017604-002	NALFON	EQ 300MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017604-003	NALFON	EQ 200MG BASE	CAPSULE / ORAL	RLD, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017604-004	NALFON	EQ 400MG BASE	CAPSULE / ORAL	RLD	2009-07-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017604-002	NALFON	EQ 300MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017604-003	NALFON	EQ 200MG BASE	CAPSULE / ORAL	RLD, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017604-004	NALFON	EQ 400MG BASE	CAPSULE / ORAL	RLD	2009-07-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017604-002	NALFON	EQ 300MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017604-003	NALFON	EQ 200MG BASE	CAPSULE / ORAL	RLD, Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017604-004	NALFON	EQ 400MG BASE	CAPSULE / ORAL	RLD	2009-07-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017604-002	NALFON	EQ 300MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017604-003	NALFON	EQ 200MG BASE	CAPSULE / ORAL	RLD, Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017604-004	NALFON	EQ 400MG BASE	CAPSULE / ORAL	RLD	2009-07-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017604-002	NALFON	EQ 300MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N017604-003	NALFON	EQ 200MG BASE	CAPSULE / ORAL	RLD, Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N017604-004	NALFON	EQ 400MG BASE	CAPSULE / ORAL	RLD	2009-07-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017604-002	NALFON	EQ 300MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	Approved before 1982		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017604-003	NALFON	EQ 200MG BASE	CAPSULE / ORAL	RLD, Approved before 1982		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017604-004	NALFON	EQ 400MG BASE	CAPSULE / ORAL	RLD	2009-07-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017604-002	NALFON	EQ 300MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	Approved before 1982		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017604-003	NALFON	EQ 200MG BASE	CAPSULE / ORAL	RLD, Approved before 1982		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017604-004	NALFON	EQ 400MG BASE	CAPSULE / ORAL	RLD	2009-07-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017604-002	NALFON	EQ 300MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	Approved before 1982		`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017604-003	NALFON	EQ 200MG BASE	CAPSULE / ORAL	RLD, Approved before 1982		`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017604-004	NALFON	EQ 400MG BASE	CAPSULE / ORAL	RLD	2009-07-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017604-002	NALFON	EQ 300MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	Approved before 1982		`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-05-31 18:47 UTC	2024-05	N017604-003	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N017604-004	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017604-003	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017604-004	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N017604-003	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N017604-004	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N017604-003	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N017604-004	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017604-003	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017604-004	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017604-003	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017604-004	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017604-003	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017604-004	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017604-003	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017604-004	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N017604-004	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N017604-004	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017604-004	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N017604-004	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N017604-004	AB	1	`e64feba35796…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0916fe0d-58e1-5e07-2471-9a804a1b0628	Product name	3	20240514
090af53b-bc54-1ac8-5eee-2f06b5d9cff9	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69336-124-10	2022-01-28	C162847	48780-1	d6a99b39-edeb-a426-e053-dadaa90af4c2	These highlights do not include all the information needed to use FENOPROFEN CALCIUM safely and effectively. See full prescribing information for Fenoprofen Calcium. FENOPROFEN CALCIUM, USP capsules, for oral use Initial U.S. Approval: 1982

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69336-124-10	FENOPROFEN CALCIUM	100 in 1 BOTTLE	CAPSULE	100		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69336-124-10	EA - Each	69336-124	a0a86aae-64f7-4be5-8161-daa94e21cef4	1	2018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69336-124	FENOPROFEN CALCIUM CAPSULE [STERLING KNIGHT PHARMACEUTICALS]	3	Legacy NDC, 1 package rows	20200125_f85ed255-fc1a-4202-a61c-857936c4c868.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
Fenoprofen Calcium	FENOPROFEN CALCIUM	Misemer Pharmaceuticals, Inc.	d33ad329-1ca6-ac2e-e053-2995a90a15c5	2026-04-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 017604 application number: NDA017604

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
0X2CW1QABJ	FENOPROFEN CALCIUM	53746-45-5	FENOPROFEN CALCIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197694	fenoprofen calcium 200 MG Oral Capsule	PSN	f85ed255-fc1a-4202-a61c-857936c4c868	3
197694	fenoprofen 200 MG Oral Capsule	SCD	f85ed255-fc1a-4202-a61c-857936c4c868	3
197694	fenoprofen (as fenoprofen calcium) 200 MG Oral Capsule	SY	f85ed255-fc1a-4202-a61c-857936c4c868	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69336-124-10	69336012410	100 CAPSULE in 1 BOTTLE (69336-124-10)	100 capsule	2016-07-06	0000-00-00	No	No	Current