FOSTER AND THRIVE ARTHRITIS PAIN

Product NDC
70677-1293
11-digit product format
706771293
Labeler code
70677
Product ID
70677-1293_23ae6e74-dad4-4cd2-b520-1b7e1a11f341
Type
HUMAN OTC DRUG
Nonproprietary name
DICLOFENAC SODIUM
Dosage form
GEL
Route
TOPICAL
Labeler
Strategic Sourcing Services LLC
Application
ANDA211253
Marketing category
ANDA
Marketing start
2025-09-27
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 43.

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
A211253-001DICLOFENAC SODIUMDICLOFENAC SODIUM1%GEL / TOPICAL2019-05-16

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-1684e616aacf4f…
2026-08-18 06:07:402026-07A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A211253-001DICLOFENAC SODIUM1%GEL / TOPICALAB2019-05-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-16782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-1687673890dc5c…
2021-03-12 10:30 UTC2021-03A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-165aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-168869cabd3fbd…
2020-11-12 02:37 UTC2020-11A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-16c0c555d07b60…
2019-12-14 00:12 UTC2019-12A211253-001DICLOFENAC SODIUM1%GEL / TOPICALAB2019-05-163f01610625f2…
2019-09-15 20:21 UTC2019-09A211253-001DICLOFENAC SODIUM1%GEL / TOPICALAB2019-05-16b00525d2431f…
2019-07-19 19:46 UTC2019-07A211253-001DICLOFENAC SODIUM1%GEL / TOPICALAB2019-05-16ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-166a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-161c564ffb4f44…
2023-12-20 04:57 UTC2023-12A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-16ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-16a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-169b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-16a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-163f0d92c62455…
2023-05-13 08:27 UTC2023-05A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-16053a50430f4f…
2023-01-26 05:58 UTC2023-01A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-163bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-163a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-16f41ea6bd6efb…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A211253-001AB174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A211253-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A211253-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A211253-001AB1ea99ee380514…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
FOSTER AND THRIVE ARTHRITIS PAIN
Listing expiration
2026-12-31

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
f9f4e55f-ffad-4df7-9b3c-1e7c3a3723c1Available 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
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
70677-1293-1FOSTER AND THRIVE ARTHRITIS PAIN100 g in 1 TUBEGEL1002
70677-1293-1FOSTER AND THRIVE ARTHRITIS PAIN1 in 1 CARTONGEL12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70677-1293-1GM - Gram70677-12932f4a2333-a6b3-4425-aa09-64bed0daaa6d12025-10-14

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 2 of 2 · 40 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MOTRIN ARTHRITIS PAINDICLOFENAC SODIUMKenvue Brands LLCdb5b4288-13ec-826b-e053-2995a90a275e2024-11-08WarningsExact identifier
application applno (ANDA): 211253
application number: ANDA211253
kirkland signature arthritis pain reliefDICLOFENAC SODIUMCostco Wholesale Company8e53e5fa-fda2-4e3a-8c5a-82435e3d51c32024-11-01WarningsExact identifier
application applno (ANDA): 211253
application number: ANDA211253
good sense arthritis painDICLOFENAC SODIUMA-S Medication Solutions5f1ca9c1-c7fe-4a91-af5e-dc22b175f0832024-09-26WarningsExact identifier
application applno (ANDA): 211253
application number: ANDA211253
diclofenac sodiumDICLOFENAC SODIUMNuCare Pharmaceuticals, Inc.20ef08a3-35cf-b4d6-e063-6394a90a012e2024-08-30WarningsExact identifier
application applno (ANDA): 211253
application number: ANDA211253
Diclofenac SodiumDICLOFENAC SODIUMNuCare Pharmaceuticals,Inc.005299ac-b6de-511f-e063-6294a90a29e02024-07-29WarningsExact identifier
application applno (ANDA): 211253
application number: ANDA211253
Diclofenac SodiumDICLOFENAC SODIUMPadagis Israel Pharmaceuticals Ltd17bd62a8-b697-48cc-b988-aac3c19c6dc52024-01-22WarningsExact identifier
application applno (ANDA): 211253
application number: ANDA211253
Diclofenac SodiumDICLOFENAC SODIUMCVS Pharmacye9ccaf95-582b-4d4d-938f-7577eaa8dffb2023-11-27WarningsExact identifier
application applno (ANDA): 211253
application number: ANDA211253
equaline arthritis pain relievingDICLOFENAC SODIUMUnited Natural Foods, Inc. dba UNFI748b6134-0c1d-4e9c-a93a-fcc6e4d0b6d02023-08-23WarningsExact identifier
application applno (ANDA): 211253
application number: ANDA211253
equate arthritis painDICLOFENAC SODIUMWal-Mart Stores Inc5e80f6b6-b3f4-4b76-82da-1fc98cb9ad1b2023-07-27WarningsExact identifier
application applno (ANDA): 211253
application number: ANDA211253
berkley and jensen arthritis painDICLOFENAC SODIUMBJWC441cf367-b293-47e8-a8fb-32e3314be7de2023-07-26WarningsExact identifier
application applno (ANDA): 211253
application number: ANDA211253
CareOne arthritis pain reliefDICLOFENAC SODIUMAmerican Sales Company69615972-b593-44fb-ae49-9441d872d84a2023-06-08WarningsExact identifier
application applno (ANDA): 211253
application number: ANDA211253
DG health arthritis painDICLOFENAC SODIUMDolgencorp Ince7f93d8f-df2b-4005-b58d-c6f10ae0e0f32023-05-24WarningsExact identifier
application applno (ANDA): 211253
application number: ANDA211253
arthritis pain relieverDICLOFENAC SODIUMPublix Super Markets Inc445de976-9a28-4e97-929f-c77aeb21c1fa2023-05-15WarningsExact identifier
application applno (ANDA): 211253
application number: ANDA211253
arthritis pain relievingDICLOFENAC SODIUMMeijer Distribution Incd46a4841-2f86-4e0e-ac79-9b1444ed4f792023-05-15WarningsExact identifier
application applno (ANDA): 211253
application number: ANDA211253
topcare athritis pain relieverDICLOFENAC SODIUMTopco Associates LLCd3e9416d-e13b-4cc7-a663-6df3534b8dbe2023-05-10WarningsExact identifier
application applno (ANDA): 211253
application number: ANDA211253
good sense arthritis painDICLOFENAC SODIUML. Perrigo Company7b32b9e4-6502-4fa3-808f-3bef9525b6a12023-05-10WarningsExact identifier
application applno (ANDA): 211253
application number: ANDA211253
arthritis pain relieverDICLOFENAC SODIUMH E Be8fe4a89-586d-461c-b242-b68e38a508b42023-03-09WarningsExact identifier
application applno (ANDA): 211253
application number: ANDA211253
Diclofenac SodiumDICLOFENAC SODIUMRite Aid Corporation1c9ea3b2-8f45-420b-87d3-dc7de0be2d5f2022-08-23WarningsExact identifier
application applno (ANDA): 211253
application number: ANDA211253
good sense arthritis painDICLOFENAC SODIUMProficient Rx LP67eacd91-8378-47e7-9bad-1e7b685aa9d42022-06-01WarningsExact identifier
application applno (ANDA): 211253
application number: ANDA211253
basic care arthritis painDICLOFENAC SODIUMAmazon.com Services LLCa8aa9016-bf2d-4727-9184-512b2570000b2022-01-06WarningsExact identifier
application applno (ANDA): 211253
application number: ANDA211253

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855633diclofenac sodium 1 % Topical GelPSNf9f4e55f-ffad-4df7-9b3c-1e7c3a3723c12
855633diclofenac sodium 0.01 MG/MG Topical GelSCDf9f4e55f-ffad-4df7-9b3c-1e7c3a3723c12
855633diclofenac sodium 1 % Topical GelSYf9f4e55f-ffad-4df7-9b3c-1e7c3a3723c12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70677-1293-1706771293011 TUBE in 1 CARTON (70677-1293-1) / 100 g in 1 TUBE1 tube2025-09-27NoNoCurrent