Home NDC 0067-8152 Voltaren
Product NDC 0067-8152
11-digit product format 000678152
Labeler code 0067
Product ID 0067-8152_71ee74f6-1c1d-4ba8-95be-9b9aefc02d3c
Type HUMAN OTC DRUG
Nonproprietary name diclofenac sodium
Dosage form GEL
Route TOPICAL
Labeler Haleon US Holdings LLC
Application NDA022122
Marketing category NDA
Marketing start 2020-05-13
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 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 · 12 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…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 N022122-001 VOLTAREN ARTHRITIS PAIN DICLOFENAC SODIUM 1% GEL / TOPICAL RLD, RS 2007-10-17
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 N022122-001 VOLTAREN ARTHRITIS PAIN 1% GEL / TOPICAL RLD, RS 2007-10-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022122-001 VOLTAREN ARTHRITIS PAIN 1% GEL / TOPICAL RLD, RS 2007-10-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022122-001 VOLTAREN ARTHRITIS PAIN 1% GEL / TOPICAL RLD, RS 2007-10-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022122-001 VOLTAREN ARTHRITIS PAIN 1% GEL / TOPICAL RLD, RS 2007-10-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022122-001 VOLTAREN ARTHRITIS PAIN 1% GEL / TOPICAL RLD, RS 2007-10-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022122-001 VOLTAREN ARTHRITIS PAIN 1% GEL / TOPICAL RLD, RS 2007-10-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022122-001 VOLTAREN ARTHRITIS PAIN 1% GEL / TOPICAL RLD, RS 2007-10-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022122-001 VOLTAREN ARTHRITIS PAIN 1% GEL / TOPICAL RLD, RS 2007-10-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022122-001 VOLTAREN ARTHRITIS PAIN 1% GEL / TOPICAL RLD, RS 2007-10-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022122-001 VOLTAREN ARTHRITIS PAIN 1% GEL / TOPICAL RLD, RS 2007-10-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022122-001 VOLTAREN ARTHRITIS PAIN 1% GEL / TOPICAL RLD, RS 2007-10-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022122-001 VOLTAREN ARTHRITIS PAIN 1% GEL / TOPICAL RLD, RS 2007-10-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022122-001 VOLTAREN ARTHRITIS PAIN 1% GEL / TOPICAL RLD, RS 2007-10-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022122-001 VOLTAREN ARTHRITIS PAIN 1% GEL / TOPICAL RLD, RS 2007-10-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022122-001 VOLTAREN ARTHRITIS PAIN 1% GEL / TOPICAL RLD, RS 2007-10-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022122-001 VOLTAREN ARTHRITIS PAIN 1% GEL / TOPICAL RLD, RS 2007-10-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022122-001 VOLTAREN ARTHRITIS PAIN 1% GEL / TOPICAL RLD, RS 2007-10-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022122-001 VOLTAREN 1% GEL / TOPICAL AB RLD, RS 2007-10-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022122-001 VOLTAREN ARTHRITIS PAIN 1% GEL / TOPICAL RLD, RS 2007-10-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022122-001 VOLTAREN ARTHRITIS PAIN 1% GEL / TOPICAL RLD, RS 2007-10-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022122-001 VOLTAREN ARTHRITIS PAIN 1% GEL / TOPICAL RLD, RS 2007-10-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022122-001 VOLTAREN ARTHRITIS PAIN 1% GEL / TOPICAL RLD, RS 2007-10-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022122-001 VOLTAREN ARTHRITIS PAIN 1% GEL / TOPICAL RLD, RS 2007-10-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022122-001 VOLTAREN ARTHRITIS PAIN 1% GEL / TOPICAL RLD, RS 2007-10-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022122-001 VOLTAREN 1% GEL / TOPICAL AB RLD, RS 2007-10-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022122-001 VOLTAREN 1% GEL / TOPICAL AB RLD, RS 2007-10-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022122-001 VOLTAREN 1% GEL / TOPICAL AB RLD, RS 2007-10-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022122-001 VOLTAREN ARTHRITIS PAIN 1% GEL / TOPICAL RLD, RS 2007-10-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N022122-001 VOLTAREN ARTHRITIS PAIN 1% GEL / TOPICAL RLD, RS 2007-10-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N022122-001 VOLTAREN ARTHRITIS PAIN 1% GEL / TOPICAL RLD, RS 2007-10-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022122-001 VOLTAREN ARTHRITIS PAIN 1% GEL / TOPICAL RLD, RS 2007-10-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022122-001 VOLTAREN ARTHRITIS PAIN 1% GEL / TOPICAL RLD, RS 2007-10-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022122-001 VOLTAREN ARTHRITIS PAIN 1% GEL / TOPICAL RLD, RS 2007-10-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022122-001 VOLTAREN ARTHRITIS PAIN 1% GEL / TOPICAL RLD, RS 2007-10-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N022122-001 VOLTAREN ARTHRITIS PAIN 1% GEL / TOPICAL RLD, RS 2007-10-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N022122-001 VOLTAREN ARTHRITIS PAIN 1% GEL / TOPICAL RLD, RS 2007-10-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022122-001 VOLTAREN ARTHRITIS PAIN 1% GEL / TOPICAL RLD, RS 2007-10-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N022122-001 VOLTAREN ARTHRITIS PAIN 1% GEL / TOPICAL RLD, RS 2007-10-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N022122-001 VOLTAREN ARTHRITIS PAIN 1% GEL / TOPICAL RLD, RS 2007-10-17 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N022122-001 VOLTAREN ARTHRITIS PAIN 1% GEL / TOPICAL RLD, RS 2007-10-17 cb3db0bc1861…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Voltaren
Brand name suffix Arthritis Pain
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DICLOFENAC SODIUM 10 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination QTG126297Q Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 855633 Internal RxNorm lookup 855635 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0067-8152 VOLTAREN ARTHRITIS PAIN (DICLOFENAC SODIUM) GEL VOLTAREN ARTHRITIS PAIN (DICLOFENAC SODIUM) KIT [HALEON US HOLDINGS LLC] 13 Current NDC, Legacy NDC, 14 package rows 20250221_30a94282-0892-442a-aa10-6525cbd4fe88.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 · 2 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 0067-8152-01 00067815201 1 TUBE in 1 CARTON (0067-8152-01) / 20 g in 1 TUBE 1 tube 2020-05-13 0000-00-00 No No Current 0067-8152-02 00067815202 1 TUBE in 1 CARTON (0067-8152-02) / 50 g in 1 TUBE 1 tube 2020-05-13 0000-00-00 No No Current 0067-8152-03 00067815203 1 TUBE in 1 CARTON (0067-8152-03) / 100 g in 1 TUBE 1 tube 2020-05-13 0000-00-00 No No Current 0067-8152-04 00067815204 1 TUBE in 1 CARTON (0067-8152-04) / 150 g in 1 TUBE 1 tube 2020-05-13 0000-00-00 No No Current 0067-8152-05 00067815205 150 g in 1 TUBE 150 g Historical 0067-8152-08 00067815208 2 TUBE in 1 CARTON (0067-8152-08) / 100 g in 1 TUBE 2 tube 2021-05-31 0000-00-00 No No Current 0067-8152-09 00067815209 1 TUBE in 1 CARTON (0067-8152-09) / 20 g in 1 TUBE 1 tube 2021-05-31 No No Current