Flanax

Product NDC: 27854-160
11-digit product format: 278540160
Labeler code: 27854
Product ID: 27854-160_15256b57-2263-447e-9a11-f3f8f7edd6c3
Type: HUMAN OTC DRUG
Nonproprietary name: Naproxen Sodium
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Belmora LLC
Application: ANDA204872
Marketing category: ANDA
Marketing start: 2018-01-15
Substance: NAPROXEN SODIUM
Active strength: 220 mg/1
Pharmacologic classes: Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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	27854-160	27854-160-00	D	Discontinued by firm		2026-08-07

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 · 11 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…`

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
A204872-001	NAPROXEN SODIUM	NAPROXEN SODIUM	220MG	TABLET / ORAL			2017-01-23

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	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204872-001	NAPROXEN SODIUM	EQ 200MG BASE	TABLET / ORAL	2017-01-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204872-001	NAPROXEN SODIUM	EQ 200MG BASE	TABLET / ORAL	2017-01-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Flanax
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NAPROXEN SODIUM	220 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9TN87S3A3C	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
849574	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
2c099d45-f03a-4161-a6af-8fe5965f2748	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fef6ad89-235f-4274-ba49-a8e53642473e	Product name	2	20250225
87fed3e6-8fba-48ef-96b0-3a7fb54b96ff	Product name	3	20230306
b5fdaaec-7251-4da6-9cb2-4e9e76939ec8	Product name	1	20200623
e76dbbc1-775d-722c-08ff-ed45e8a80def	Product name	3	20181002
6f4f4521-fd56-1ae6-888b-3b021bd75c7c	Product name	1	20140508
ce67e27d-1d21-5465-4409-b0662dd99d4d	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
27854-160-00	Flanax	100 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	100	14
27854-160-00	Flanax	1 in 1 CARTON	TABLET, FILM COATED	1	14
27854-160-01	Flanax	1 in 1 CARTON	TABLET, FILM COATED	1	14
27854-160-01	Flanax	10 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	10	14
27854-160-24	Flanax	24 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	24	14
27854-160-24	Flanax	1 in 1 CARTON	TABLET, FILM COATED	1	14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
27854-160-24	EA - Each	27854-160	6047044f-79dd-4834-8912-ab2e5b59507b	1	2024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
27854-160	FLANAX (NAPROXEN SODIUM) TABLET, FILM COATED [BELMORA LLC]	12	Current NDC, Legacy NDC, 6 package rows	20240825_2c099d45-f03a-4161-a6af-8fe5965f2748.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 2 · 28 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Naproxen	NAPROXEN SODIUM	Preferred Pharmaceuticals, Inc.	20eb9d9f-11df-464f-a1b0-949f8fda4042	2026-07-28	Warnings	Exact identifier application applno (ANDA): 204872 application number: ANDA204872
Back and Muscle Pain	NAPROXEN SODIUM	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	4039504c-e612-4503-854a-62ee06780956	2026-07-13	Warnings	Exact identifier application applno (ANDA): 204872 application number: ANDA204872
Naproxen Sodium	NAPROXEN SODIUM	Lidl US LLC	3d01220c-c5ec-4604-8cef-9ecb807ccd53	2026-06-22	Warnings	Exact identifier application applno (ANDA): 204872 application number: ANDA204872
Naproxen Sodium	NAPROXEN SODIUM	Rite Aid Corporation	134e5ec6-c42a-43b6-adf2-2d7546875ead	2026-06-19	Warnings	Exact identifier application applno (ANDA): 204872 application number: ANDA204872
Naproxen Headache Pain	NAPROXEN SODIUM	L.N.K. International, Inc.	6161b881-f422-47ae-86ba-a28d669bce79	2026-06-18	Warnings	Exact identifier application applno (ANDA): 204872 application number: ANDA204872
Naproxen	NAPROXEN SODIUM	Family Dollar Services Inc	d9c63e1f-c2ad-434b-8a21-7fff21b7477b	2026-06-03	Warnings	Exact identifier application applno (ANDA): 204872 application number: ANDA204872
Naproxen Sodium	NAPROXEN SODIUM	Rite Aid Corporation	e6277515-c606-4535-9c29-08cade045aee	2026-05-14	Warnings	Exact identifier application applno (ANDA): 204872 application number: ANDA204872
Naproxen Back and Muscle Pain	NAPROXEN SODIUM	L.N.K. International, Inc.	68944663-0dc0-4d3a-a36b-019061bdbfa0	2026-03-09	Warnings	Exact identifier application applno (ANDA): 204872 application number: ANDA204872
AnaDent	NAPROXEN SODIUM	Belmora LLC	236674db-da4d-415c-a160-7086eaf5bff5	2026-03-03	Warnings	Exact identifier application applno (ANDA): 204872 application number: ANDA204872
Naproxen Sodium	NAPROXEN SODIUM	L.N.K. International, Inc.	717518e4-2537-4229-b765-c6acfe963d4b	2026-02-25	Warnings	Exact identifier application applno (ANDA): 204872 application number: ANDA204872
Naproxen Sodium	NAPROXEN SODIUM	Better Living Brands, LLC	3eeb07fe-fcf1-4ea7-b0c2-9cb04f88c041	2026-02-13	Warnings	Exact identifier application applno (ANDA): 204872 application number: ANDA204872
Back and Muscle Pain	NAPROXEN SODIUM	Rite Aid Corporation	e162bd50-f94a-4c76-8f1b-62114f283809	2026-02-11	Warnings	Exact identifier application applno (ANDA): 204872 application number: ANDA204872
Flanax Menstrual Pain Reliever	NAPROXEN SODIUM	Belmora LLC	2b4135b3-389c-46e2-ae86-7674c2ab9a32	2026-01-27	Warnings	Exact identifier application applno (ANDA): 204872 application number: ANDA204872
Flanax	NAPROXEN SODIUM	Belmora LLC	2c099d45-f03a-4161-a6af-8fe5965f2748	2026-01-06	Warnings	Exact identifier application applno (ANDA): 204872 application number: ANDA204872 ndc (product): 27854-160
All Day Pain Relief	NAPROXEN SODIUM	WALMART INC.	c4909e43-57ba-44bc-a234-a02cc884891c	2025-12-11	Warnings	Exact identifier application applno (ANDA): 204872 application number: ANDA204872
24/7 Life by 7-Eleven Naproxen Sodium	NAPROXEN SODIUM TABLET, FILM COATED	Lil' Drug Store Products, Inc.	44716954-006a-4c56-e063-6294a90a0f14	2025-11-25	Warnings	Exact identifier application applno (ANDA): 204872 application number: ANDA204872
Naproxen Sodium	NAPROXEN SODIUM	Athlete's Needs Inc	d5984c9d-3941-45d6-8392-87564b2faae0	2025-11-15	Warnings	Exact identifier application applno (ANDA): 204872 application number: ANDA204872
Naproxen	NAPROXEN SODIUM	Better Living Brands, LLC	43745d42-f859-4168-a2dd-2c8ae47ae590	2025-10-28	Warnings	Exact identifier application applno (ANDA): 204872 application number: ANDA204872
Naproxen	NAPROXEN SODIUM	Family Dollar Services Inc	b6205032-f5c6-494a-8b87-adbbbc3982e7	2025-10-27	Warnings	Exact identifier application applno (ANDA): 204872 application number: ANDA204872
Naproxen	NAPROXEN SODIUM	Amerisource Bergen	1e2e6e3a-b095-4d5b-86fe-61eb44a87cf0	2025-10-20	Warnings	Exact identifier application applno (ANDA): 204872 application number: ANDA204872

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9TN87S3A3C	NAPROXEN SODIUM	26159-34-2	NAPROXEN SODIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
849574	naproxen sodium 220 MG Oral Tablet	PSN	2c099d45-f03a-4161-a6af-8fe5965f2748	14
849574	naproxen sodium 220 MG Oral Tablet	SCD	2c099d45-f03a-4161-a6af-8fe5965f2748	14
849574	naproxen sodium 220 MG (as naproxen 200 MG) Oral Tablet	SY	2c099d45-f03a-4161-a6af-8fe5965f2748	14

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
27854-160-00	27854016000	1 BOTTLE, PLASTIC in 1 CARTON (27854-160-00) > 100 TABLET, COATED in 1 BOTTLE, PLASTIC	2018-01-15	0000-00-00	No	No	Current
27854-160-01	27854016001	1 BOTTLE, PLASTIC in 1 CARTON (27854-160-01) / 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC	2018-01-15	0000-00-00	No	No	Current
27854-160-24	27854016024	1 BOTTLE, PLASTIC in 1 CARTON (27854-160-24) / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC	2018-01-15	0000-00-00	No	No	Current