Naproxen

Manufacturer: Central Packaging | Central Packaging, LLC
Effective date: 2021-02-25
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 20:35:43

Label at a glance#

ProductNaproxen

Active ingredientNAPROXEN

Label structure2 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Naproxen Tablets are indicated for:

the relief of the signs and symptoms of:

rheumatoid arthritis
osteoarthritis
ankylosing spondylitis
polyarticular juvenile idiopathic arthritis
tendonitis
bursitis
acute gout

the management of:

pain
primary dysmenorrhea

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Naproxen - Bottle

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
198014	naproxen 500 MG Oral Tablet	PSN	1
198014	naproxen 500 MG Oral Tablet	SCD	1

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
NAPROXEN Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20191108

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	Strength	SPL version
80175-0436-6	Naproxen	60 in 1 BOTTLE	TABLET	60		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80175-0436	NAPROXEN TABLET [CENTRAL PACKAGING]	1	Legacy NDC, 1 package rows	20210226_bc2c6b1e-999d-91a7-e053-2a95a90a9d1a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50228-436-01	EA - Each	50228-436	a4e0c7b6-1055-45f5-9618-a2a247394891	1	2020-04-20
50228-436-05	EA - Each	50228-436	5225e611-4788-4429-9e5d-86a023f33fa0	1	2020-04-20

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 1 matching rows.

Naproxen

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
80175-0436	80175-0436-6
50228-436

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
NAPROXEN	57Y76R9ATQ	ACTIB

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

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

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	TE codes	Approval date
A212517-001	NAPROXEN	NAPROXEN	250MG	TABLET / ORAL	AB	2020-02-21
A212517-002	NAPROXEN	NAPROXEN	375MG	TABLET / ORAL	AB	2020-02-21
A212517-003	NAPROXEN	NAPROXEN	500MG	TABLET / ORAL	AB	2020-02-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A212517-001	AB
A212517-002	AB
A212517-003	AB

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 3 · 117 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A212517-001	NAPROXEN	250MG	TABLET / ORAL	AB	2020-02-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212517-002	NAPROXEN	375MG	TABLET / ORAL	AB	2020-02-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212517-003	NAPROXEN	500MG	TABLET / ORAL	AB	2020-02-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212517-001	NAPROXEN	250MG	TABLET / ORAL	AB	2020-02-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212517-002	NAPROXEN	375MG	TABLET / ORAL	AB	2020-02-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212517-003	NAPROXEN	500MG	TABLET / ORAL	AB	2020-02-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212517-001	NAPROXEN	250MG	TABLET / ORAL	AB	2020-02-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212517-002	NAPROXEN	375MG	TABLET / ORAL	AB	2020-02-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212517-003	NAPROXEN	500MG	TABLET / ORAL	AB	2020-02-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212517-001	NAPROXEN	250MG	TABLET / ORAL	AB	2020-02-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212517-002	NAPROXEN	375MG	TABLET / ORAL	AB	2020-02-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212517-003	NAPROXEN	500MG	TABLET / ORAL	AB	2020-02-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212517-001	NAPROXEN	250MG	TABLET / ORAL	AB	2020-02-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212517-002	NAPROXEN	375MG	TABLET / ORAL	AB	2020-02-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212517-003	NAPROXEN	500MG	TABLET / ORAL	AB	2020-02-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212517-001	NAPROXEN	250MG	TABLET / ORAL	AB	2020-02-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212517-002	NAPROXEN	375MG	TABLET / ORAL	AB	2020-02-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212517-003	NAPROXEN	500MG	TABLET / ORAL	AB	2020-02-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212517-001	NAPROXEN	250MG	TABLET / ORAL	AB	2020-02-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212517-002	NAPROXEN	375MG	TABLET / ORAL	AB	2020-02-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212517-003	NAPROXEN	500MG	TABLET / ORAL	AB	2020-02-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212517-001	NAPROXEN	250MG	TABLET / ORAL	AB	2020-02-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212517-002	NAPROXEN	375MG	TABLET / ORAL	AB	2020-02-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212517-003	NAPROXEN	500MG	TABLET / ORAL	AB	2020-02-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212517-001	NAPROXEN	250MG	TABLET / ORAL	AB	2020-02-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212517-002	NAPROXEN	375MG	TABLET / ORAL	AB	2020-02-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212517-003	NAPROXEN	500MG	TABLET / ORAL	AB	2020-02-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212517-001	NAPROXEN	250MG	TABLET / ORAL	AB	2020-02-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212517-002	NAPROXEN	375MG	TABLET / ORAL	AB	2020-02-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212517-003	NAPROXEN	500MG	TABLET / ORAL	AB	2020-02-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212517-001	NAPROXEN	250MG	TABLET / ORAL	AB	2020-02-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212517-002	NAPROXEN	375MG	TABLET / ORAL	AB	2020-02-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212517-003	NAPROXEN	500MG	TABLET / ORAL	AB	2020-02-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212517-001	NAPROXEN	250MG	TABLET / ORAL	AB	2020-02-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212517-002	NAPROXEN	375MG	TABLET / ORAL	AB	2020-02-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212517-003	NAPROXEN	500MG	TABLET / ORAL	AB	2020-02-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212517-001	NAPROXEN	250MG	TABLET / ORAL	AB	2020-02-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212517-002	NAPROXEN	375MG	TABLET / ORAL	AB	2020-02-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212517-003	NAPROXEN	500MG	TABLET / ORAL	AB	2020-02-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212517-001	NAPROXEN	250MG	TABLET / ORAL	AB	2020-02-21	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 117 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A212517-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212517-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212517-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212517-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212517-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212517-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212517-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212517-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212517-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212517-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212517-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212517-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212517-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212517-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212517-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212517-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212517-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212517-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212517-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212517-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212517-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212517-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212517-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212517-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212517-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212517-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212517-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212517-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212517-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212517-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212517-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212517-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212517-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212517-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212517-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212517-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212517-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212517-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212517-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212517-001	AB	1	`301d65b070ca…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Naproxen	NAPROXEN	ScieGen Pharmaceuticals, Inc.	81e22c1f-f94d-46e9-8b7d-72dc2518319e	2026-03-18	Boxed warning, Warnings, Adverse reactions	Exact identifier ndc (product): 50228-436
bc2c6b1e-999e-91a7-e053-2a95a90a9d1a			bc2c6b1e-999d-91a7-e053-2a95a90a9d1a	2021-02-25		Exact identifier spl id: bc2c6b1e-999e-91a7-e053-2a95a90a9d1a spl set id: bc2c6b1e-999d-91a7-e053-2a95a90a9d1a

Reported adverse events (FAERS/openFDA)#

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