Home NDC 36800-368 TopCare All Day Pain Relief
Product NDC 36800-368
11-digit product format 368000368
Labeler code 36800
Product ID 36800-368_526325f7-8883-4c20-802c-544f75249168
Type HUMAN OTC DRUG
Nonproprietary name Naproxen Sodium
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Topco Associates LLC
Application ANDA074661
Marketing category ANDA
Marketing start 1997-01-14
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 2026-12-31
Current FDA listing Yes 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 · 22 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A074661-001 NAPROXEN SODIUM NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13
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 Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A074661-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074661-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074661-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074661-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074661-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074661-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074661-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074661-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074661-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074661-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074661-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074661-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074661-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074661-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074661-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074661-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074661-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074661-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074661-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A074661-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A074661-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A074661-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A074661-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A074661-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A074661-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A074661-001 NAPROXEN SODIUM EQ 200MG BASE TABLET / ORAL 1997-01-13 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A074661-001 NAPROXEN SODIUM EQ 200MG BASE TABLET / ORAL 1997-01-13 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A074661-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A074661-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A074661-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A074661-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A074661-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A074661-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A074661-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A074661-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A074661-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A074661-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A074661-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A074661-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A074661-001 NAPROXEN SODIUM 220MG TABLET / ORAL 1997-01-13 cb3db0bc1861…
Additional Listing Data#
Finished product Yes
Brand name base TopCare All Day Pain Relief
Listing expiration 2026-12-31 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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 36800-368-62 TopCare All Day Pain Relief 24 in 1 BOTTLE TABLET, FILM COATED 24 11 36800-368-62 TopCare All Day Pain Relief 1 in 1 CARTON TABLET, FILM COATED 1 11 36800-368-71 TopCare All Day Pain Relief 50 in 1 BOTTLE TABLET, FILM COATED 50 11 36800-368-71 TopCare All Day Pain Relief 1 in 1 CARTON TABLET, FILM COATED 1 11 36800-368-75 TopCare All Day Pain Relief 90 in 1 BOTTLE TABLET, FILM COATED 90 11 36800-368-75 TopCare All Day Pain Relief 1 in 1 CARTON TABLET, FILM COATED 1 11 36800-368-76 TopCare All Day Pain Relief 1 in 1 CARTON TABLET, FILM COATED 1 11 36800-368-76 TopCare All Day Pain Relief 120 in 1 BOTTLE TABLET, FILM COATED 120 11 36800-368-78 TopCare All Day Pain Relief 1 in 1 CARTON TABLET, FILM COATED 1 11 36800-368-78 TopCare All Day Pain Relief 100 in 1 BOTTLE TABLET, FILM COATED 100 11 36800-368-79 TopCare All Day Pain Relief 400 in 1 BOTTLE TABLET, FILM COATED 400 11 36800-368-82 TopCare All Day Pain Relief 1 in 1 CARTON TABLET, FILM COATED 1 11 36800-368-82 TopCare All Day Pain Relief 200 in 1 BOTTLE TABLET, FILM COATED 200 11
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded NAPROXEN SODIUM ACTIVE INGREDIENT 9TN87S3A3C TOPCARE ALL DAY PAIN RELIEF (NAPROXEN SODIUM) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] 3 NAPROXEN ACTIVE MOIETY 57Y76R9ATQ TOPCARE ALL DAY PAIN RELIEF (NAPROXEN SODIUM) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U TOPCARE ALL DAY PAIN RELIEF (NAPROXEN SODIUM) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] 3 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO TOPCARE ALL DAY PAIN RELIEF (NAPROXEN SODIUM) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 TOPCARE ALL DAY PAIN RELIEF (NAPROXEN SODIUM) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] 3 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A TOPCARE ALL DAY PAIN RELIEF (NAPROXEN SODIUM) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] 3 POVIDONES INACTIVE INGREDIENT FZ989GH94E TOPCARE ALL DAY PAIN RELIEF (NAPROXEN SODIUM) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] 3 TALC INACTIVE INGREDIENT 7SEV7J4R1U TOPCARE ALL DAY PAIN RELIEF (NAPROXEN SODIUM) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP TOPCARE ALL DAY PAIN RELIEF (NAPROXEN SODIUM) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 36800-368 TOPCARE ALL DAY PAIN RELIEF (NAPROXEN SODIUM) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] 10 Current NDC, Legacy NDC, 13 package rows 20241001_079eccdd-33bd-4b5c-bf46-9aef78559082.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 3 · 56 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 36800-368-62 36800036862 1 BOTTLE in 1 CARTON (36800-368-62) / 24 TABLET, FILM COATED in 1 BOTTLE 1 bottle 1997-07-22 0000-00-00 No No Current 36800-368-71 36800036871 1 BOTTLE in 1 CARTON (36800-368-71) / 50 TABLET, FILM COATED in 1 BOTTLE 1 bottle 1997-01-14 0000-00-00 No No Current 36800-368-75 36800036875 1 BOTTLE in 1 CARTON (36800-368-75) / 90 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2022-07-12 0000-00-00 No No Current 36800-368-76 36800036876 1 BOTTLE in 1 CARTON (36800-368-76) / 120 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2007-06-29 0000-00-00 No No Current 36800-368-78 36800036878 1 BOTTLE in 1 CARTON (36800-368-78) > 100 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2002-06-11 0000-00-00 No No Current 36800-368-79 36800036879 400 TABLET, FILM COATED in 1 BOTTLE (36800-368-79) 2019-12-30 0000-00-00 No No Current 36800-368-82 36800036882 1 BOTTLE in 1 CARTON (36800-368-82) / 200 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2004-01-27 0000-00-00 No No Current