FDA.reportPublic FDA data

Family Dollar

Product NDC
55319-388
Requested package NDC
55319-388-82
11-digit product format
553190388
Labeler code
55319
Product ID
55319-388_c77a91b6-aa68-146f-e053-2a95a90a6483
Type
HUMAN OTC DRUG
Nonproprietary name
Benzocaine
Dosage form
LIQUID
Route
ORAL
Labeler
Family Dollar Services Inc.
Application
part356
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2013-08-01
Marketing end
0000-00-00
Substance
BENZOCAINE
Active strength
20 g/100g
NDC exclude flag
No
Listing certified through
2022-12-31
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 packagepackage55319-38855319-388-82DDiscontinued by firm2026-10-12

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 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…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55319-388-822025-01-30C16284748780-12cef2736-6bab-d83d-e063-dadaa90ab31f5820388 Family Wellness Max Str Oral Pain Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55319-388-82Family DollarOral Pain Relief14.7 g in 1 BOTTLELIQUID14.77
55319-388-82Family DollarOral Pain Relief1 in 1 CARTONLIQUID17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55319-388FAMILY DOLLAR ORAL PAIN RELIEF (BENZOCAINE) LIQUID [FAMILY DOLLAR SERVICES INC.]7Legacy NDC, 2 package rows20230615_ddd0a678-3cee-42a1-a34e-a870e2dd4a4f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308657benzocaine 20 % Mucous Membrane Topical SolutionPSNddd0a678-3cee-42a1-a34e-a870e2dd4a4f7
308657benzocaine 200 MG/ML Mucous Membrane Topical SolutionSCDddd0a678-3cee-42a1-a34e-a870e2dd4a4f7
308657benzocaine 20 % Mucous Membrane Topical SolutionSYddd0a678-3cee-42a1-a34e-a870e2dd4a4f7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55319-388-82553190388821 BOTTLE in 1 CARTON (55319-388-82) > 14.7 g in 1 BOTTLE1 bottle2013-08-010000-00-00NoNoCurrent