FDA.reportPublic FDA data

PainBloc24

Product NDC
71226-001
Requested package NDC
71226-001-02
11-digit product format
712260001
Labeler code
71226
Product ID
71226-001_d4c1f183-39e7-6be3-e053-2995a90aedf1
Type
HUMAN OTC DRUG
Nonproprietary name
Capsaicin 0.25%
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Vizuri Health Sciences LLC
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2019-11-05
Marketing end
0000-00-00
Substance
CAPSAICIN
Active strength
3 mg/mL
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage71226-00171226-001-02IInactivated by FDA2026-10-05

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 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Indexing SPL, Related label table
NDCIndexing SPLRelated label
71226-001-011030e365-0a45-111a-e063-dadaa90a10e2Vizuri PainBloc ® 24
71226-001-021030e365-0a45-111a-e063-dadaa90a10e2Vizuri PainBloc ® 24
71226-001-031030e365-0a45-111a-e063-dadaa90a10e2Vizuri PainBloc ® 24
71226-001-061030e365-53da-111a-e063-dadaa90a10e2PainBloc24

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71226-001-01PainBloc2430 mL in 1 BOTTLE, WITH APPLICATORSOLUTION306
71226-001-01PainBloc241 in 1 CARTONSOLUTION16
71226-001-02PainBloc241 in 1 CARTONSOLUTION16
71226-001-02PainBloc2414 mL in 1 BOTTLE, WITH APPLICATORSOLUTION146
71226-001-03PainBloc2445 mL in 1 BOTTLE, WITH APPLICATORSOLUTION456
71226-001-03PainBloc241 in 1 CARTONSOLUTION16
71226-001-06PainBloc241 in 1 CARTONSOLUTION13
71226-001-06PainBloc2412 mL in 1 BOTTLE, WITH APPLICATORSOLUTION123

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71226-001PAINBLOC24 (CAPSAICIN 0.25%) SOLUTION [VIZURI HEALTH SCIENCES LLC]6Legacy NDC, 6 package rows20220105_d856dbc8-20e7-4f47-ac7b-81bb94362edc.zip
71226-001PAINBLOC24 (CAPSAICIN 0.25%) SOLUTION [VIZURI HEALTH SCIENCES LLC]3Legacy NDC, 2 package rows20220105_969aa707-0e6c-db5f-e053-2995a90a840a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1874747capsaicin 0.25 % Topical SolutionPSNd856dbc8-20e7-4f47-ac7b-81bb94362edc6
1874747capsaicin 2.5 MG/ML Topical SolutionSCDd856dbc8-20e7-4f47-ac7b-81bb94362edc6
1874747capsaicin 0.25 % Topical SolutionSYd856dbc8-20e7-4f47-ac7b-81bb94362edc6
1874747capsaicin 0.25 % Topical SolutionPSN969aa707-0e6c-db5f-e053-2995a90a840a3
1874747capsaicin 2.5 MG/ML Topical SolutionSCD969aa707-0e6c-db5f-e053-2995a90a840a3
1874747capsaicin 0.25 % Topical SolutionSY969aa707-0e6c-db5f-e053-2995a90a840a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71226-001-02712260001021 BOTTLE, WITH APPLICATOR in 1 CARTON (71226-001-02) > 14 mL in 1 BOTTLE, WITH APPLICATOR2017-08-010000-00-00NoNoCurrent