AMAZON BASIC CARE ARTHRITIS PAIN

Product NDC
72288-624
11-digit product format
722880624
Labeler code
72288
Product ID
72288-624_9aaf667d-6ca6-4cc3-98b0-aba0571aeee0
Type
HUMAN OTC DRUG
Nonproprietary name
Diclofenac Sodium
Dosage form
GEL
Route
TOPICAL
Labeler
Amazon.com Services LLC
Application
ANDA204306
Marketing category
ANDA
Marketing start
2024-05-15
Substance
DICLOFENAC SODIUM
Active strength
10 mg/g
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], 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 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A204306-001DICLOFENAC SODIUMDICLOFENAC SODIUM1%GEL / TOPICAL2019-05-06

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A204306-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A204306-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204306-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A204306-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204306-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204306-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204306-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204306-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204306-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204306-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204306-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204306-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204306-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204306-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204306-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-068072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204306-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-065c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A204306-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-065d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A204306-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-064b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A204306-001DICLOFENAC SODIUM1%GEL / TOPICALAB2019-05-0674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A204306-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-06bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A204306-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-06782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A204306-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-0687673890dc5c…
2021-03-12 10:30 UTC2021-03A204306-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-065aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A204306-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-068869cabd3fbd…
2020-11-12 02:37 UTC2020-11A204306-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-06c0c555d07b60…
2019-12-14 00:12 UTC2019-12A204306-001DICLOFENAC SODIUM1%GEL / TOPICALAB2019-05-063f01610625f2…
2019-09-15 20:21 UTC2019-09A204306-001DICLOFENAC SODIUM1%GEL / TOPICALAB2019-05-06b00525d2431f…
2019-07-19 19:46 UTC2019-07A204306-001DICLOFENAC SODIUM1%GEL / TOPICALAB2019-05-06ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A204306-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-066a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A204306-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-061c564ffb4f44…
2023-12-20 04:57 UTC2023-12A204306-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-06ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A204306-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-06a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A204306-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-069b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A204306-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-06a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A204306-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-063f0d92c62455…
2023-05-13 08:27 UTC2023-05A204306-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-06053a50430f4f…
2023-01-26 05:58 UTC2023-01A204306-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-063bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A204306-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-063a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A204306-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-06f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A204306-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-06e64feba35796…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A204306-001AB174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A204306-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A204306-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A204306-001AB1ea99ee380514…

Additional Listing Data#

Finished product
Yes
Brand name base
AMAZON BASIC CARE ARTHRITIS PAIN
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DICLOFENAC SODIUM10 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
QTG126297QInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
855633Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
113e2f87-c408-3e44-e063-6394a90a0a7fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
111d457e-3138-4512-b0ba-d0cd760c4055Product name320250225
0426261e-1bb9-b78b-abd2-80da765a7e3eProduct name220240513
7b6158ae-c3f4-3d73-c35f-6f5d18b9efd7Product name520240320
0ac2f11f-f58d-baf2-71a0-680993b48a61Product name220231211
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
855d63c3-b090-4636-8fc7-6d39ad23c44fProduct name120230829
bb58f410-04be-65dd-9211-e89ead899698Product name620230323
0fcbc38a-8b29-3348-1cef-5222ea53484fProduct name420220516
c4e1eedc-aca2-4551-8382-89144ed9d049Product name320220126
8d368a34-1453-43ea-828d-0dbcd72b8794Product name820210622
d6bab9d2-edce-a213-4796-226ab15472c3Product name620200616
2487e6ef-d419-42fc-aaf8-7acc805d2370Product name220170718
e071c814-e5e7-e7ed-ec76-428765d9c66bProduct name220151120
93148e06-b8d7-4e6c-853e-62f807d17fbbProduct name120151014
dbb00be6-fb1c-4b0a-a770-31f7e05e247eProduct name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72288-624-03AMAZON BASIC CARE ARTHRITIS PAIN1 in 1 CARTONGEL12
72288-624-03AMAZON BASIC CARE ARTHRITIS PAIN50 g in 1 TUBEGEL502
72288-624-07AMAZON BASIC CARE ARTHRITIS PAIN100 g in 1 TUBEGEL1002
72288-624-07AMAZON BASIC CARE ARTHRITIS PAIN1 in 1 CARTONGEL12
72288-624-08AMAZON BASIC CARE ARTHRITIS PAIN150 g in 1 TUBEGEL1502
72288-624-08AMAZON BASIC CARE ARTHRITIS PAIN1 in 1 CARTONGEL12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72288-624AMAZON BASIC CARE ARTHRITIS PAIN (DICLOFENAC SODIUM) GEL [AMAZON.COM SERVICES LLC]2Current NDC, 6 package rows20240518_113e2f87-c408-3e44-e063-6394a90a0a7f.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 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AMAZON BASIC CARE ARTHRITIS PAINDICLOFENAC SODIUMAmazon.com Services LLC113e2f87-c408-3e44-e063-6394a90a0a7f2026-08-20WarningsExact identifier
application applno (ANDA): 204306
application number: ANDA204306
ndc (product): 72288-624
Diclofenac SodiumDICLOFENAC SODIUMPreferred Pharmaceuticals Inc.226da8a2-807d-4784-8d33-b434f3951a522026-08-12WarningsExact identifier
application applno (ANDA): 204306
application number: ANDA204306
Diclofenac SodiumDICLOFENAC SODIUMPreferred Pharmaceuticals Inc.09643e65-f301-4891-96f4-d78bf3621e232026-07-02WarningsExact identifier
application applno (ANDA): 204306
application number: ANDA204306
Diclofenac SodiumDICLOFENAC SODIUMSportpharm LLC929f71ab-f0c8-4331-800d-ed4a172e647e2026-01-14WarningsExact identifier
application applno (ANDA): 204306
application number: ANDA204306
Diclofenac SodiumDICLOFENAC SODIUMRedpharm Drug37362eb4-db16-f4ad-e063-6394a90a42aa2025-12-13WarningsExact identifier
application applno (ANDA): 204306
application number: ANDA204306
Diclofenac SodiumDICLOFENAC SODIUMAurobindo Pharma Limitede5c0863a-edb7-4f46-a396-c9b2d8785cf82025-11-19WarningsExact identifier
application applno (ANDA): 204306
application number: ANDA204306
Diclofenac SodiumDICLOFENAC SODIUMGERI-CARE PHARMACEUTICAL CORPfc08e58c-6323-e667-e053-6394a90ab7542025-04-21WarningsExact identifier
application applno (ANDA): 204306
application number: ANDA204306
DICLOFENAC SODIUMDICLOFENAC SODIUMINNOVUS PHARMACEUTICALS, INC.ad9d2c28-21bc-4f81-9c90-cce6a96d976a2025-03-25WarningsExact identifier
application applno (ANDA): 204306
application number: ANDA204306
Diclofenac SodiumDICLOFENAC SODIUMHarris Teeter17ed520d-bfbe-4a33-e063-6394a90aa0f62024-08-30WarningsExact identifier
application applno (ANDA): 204306
application number: ANDA204306
Diclofenac SodiumDICLOFENAC SODIUMAurohealth LLC81e964ff-6622-4054-bf01-6ed6eef6778f2024-07-06WarningsExact identifier
application applno (ANDA): 204306
application number: ANDA204306
Diclofenac SodiumDICLOFENAC SODIUMKROGER COMPANY15e59aac-a642-91e4-e063-6294a90a11752024-06-28WarningsExact identifier
application applno (ANDA): 204306
application number: ANDA204306
Diclofenac SodiumDICLOFENAC SODIUMAurohealth LLC2a599579-b2b0-4423-8e30-fe04bf8158702023-08-11WarningsExact identifier
application applno (ANDA): 204306
application number: ANDA204306

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855633diclofenac sodium 1 % Topical GelPSN113e2f87-c408-3e44-e063-6394a90a0a7f2
855633diclofenac sodium 0.01 MG/MG Topical GelSCD113e2f87-c408-3e44-e063-6394a90a0a7f2
855633diclofenac sodium 1 % Topical GelSY113e2f87-c408-3e44-e063-6394a90a0a7f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72288-624-03722880624031 TUBE in 1 CARTON (72288-624-03) / 50 g in 1 TUBE1 tube2024-05-15NoNoCurrent
72288-624-07722880624071 TUBE in 1 CARTON (72288-624-07) / 100 g in 1 TUBE1 tube2024-05-15NoNoCurrent
72288-624-08722880624081 TUBE in 1 CARTON (72288-624-08) / 150 g in 1 TUBE1 tube2024-05-15NoNoCurrent