FDA.reportPublic FDA data

Sore Relief

Product NDC
69804-077
Requested package NDC
69804-077-14
11-digit product format
698040077
Labeler code
69804
Product ID
69804-077_a45dfdb4-2c47-3409-e053-2995a90ae8d3
Type
HUMAN OTC DRUG
Nonproprietary name
lidocaine hcl
Dosage form
GEL
Route
TOPICAL
Labeler
ridge properties llc
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2017-11-27
Marketing end
0000-00-00
Substance
LIDOCAINE HYDROCHLORIDE
Active strength
40 mg/1000mg
NDC exclude flag
No
Listing certified through
2021-12-31
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 packagepackage69804-07769804-077-14IInactivated 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 · 19 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…
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-278dfbde2a14a4…c9ff85d89658…

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
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
69804-077-142021-07-235df7d5a9-e4cd-1b8e-e053-2a91aa0a4ffa
69804-077-152021-07-235df7d5a9-e4cd-1b8e-e053-2a91aa0a4ffa
69804-077-162021-07-235df7d5a9-e4cd-1b8e-e053-2a91aa0a4ffa
69804-077-142020-02-085df7d5a9-e4cd-1b8e-e053-2a91aa0a4ffa
69804-077-152020-02-085df7d5a9-e4cd-1b8e-e053-2a91aa0a4ffa
69804-077-162020-02-085df7d5a9-e4cd-1b8e-e053-2a91aa0a4ffa
69804-077-142020-01-315df7d5a9-e4cd-1b8e-e053-2a91aa0a4ffa
69804-077-152020-01-315df7d5a9-e4cd-1b8e-e053-2a91aa0a4ffa
69804-077-162020-01-315df7d5a9-e4cd-1b8e-e053-2a91aa0a4ffa

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69804-077-14Sore Relief28500 mg in 1 BOTTLE, DISPENSINGGEL285003
69804-077-15Sore Relief56700 mg in 1 BOTTLE, DISPENSINGGEL567003
69804-077-16Sore Relief113400 mg in 1 BOTTLE, DISPENSINGGEL1134003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69804-077SORE RELIEF (LIDOCAINE HCL) GEL [RIDGE PROPERTIES LLC]3Legacy NDC, 3 package rows20200429_5df7d5a9-e4cd-1b8e-e053-2a91aa0a4ffa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1010077lidocaine HCl 4 % Topical GelPSN5df7d5a9-e4cd-1b8e-e053-2a91aa0a4ffa3
1010077lidocaine hydrochloride 0.04 MG/MG Topical GelSCD5df7d5a9-e4cd-1b8e-e053-2a91aa0a4ffa3
1010077lidocaine hydrochloride 4 % Topical GelSY5df7d5a9-e4cd-1b8e-e053-2a91aa0a4ffa3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69804-077-146980400771428500 mg in 1 BOTTLE, DISPENSING (69804-077-14) 28500 mg2017-11-270000-00-00NoNoCurrent