Home NDC 71683-004-01 JO Prolonger with Benzocaine
Product NDC 71683-004
Requested package NDC 71683-004-01
11-digit product format 716830004
Labeler code 71683
Product ID 71683-004_3e9d73b4-5174-617d-e063-6294a90ad0e9
Type HUMAN OTC DRUG
Nonproprietary name Benzocaine
Dosage form SPRAY
Route TOPICAL
Labeler CC Wellness LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2015-09-03
Substance BENZOCAINE
Active strength 7.5 g/100mL
Pharmacologic classes Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [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 · 6 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 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…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
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 JO Prolonger with Benzocaine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZOCAINE 7.5 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination U3RSY48JW5 Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71683-004-01 JO Prolonger with Benzocaine 1 in 1 BOX SPRAY 1 3 71683-004-02 JO Prolonger with Benzocaine 60 mL in 1 BOTTLE, SPRAY SPRAY 60 3
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 18 of 153 · 3,057 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 71683-004-01 71683000401 1 BOTTLE, SPRAY in 1 BOX (71683-004-01) / 60 mL in 1 BOTTLE, SPRAY (71683-004-02) 2015-09-03 0000-00-00 No No Current