JO Prolonger with Benzocaine

Product NDC
71683-004
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 · 12 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage71683-004-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage71683-004-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage71683-004-01557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage71683-004-018af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage71683-004-01834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage71683-004-011332a3947898…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
IngredientStrength
BENZOCAINE7.5 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
U3RSY48JW5Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
d955f612-1267-f1be-e053-2995a90a5345Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71683-004-012024-01-30C16284748780-11030e365-2224-111a-e063-dadaa90a10e2d955f612-1267-f1be-e053-2995a90a5345

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71683-004-01JO Prolonger with Benzocaine1 in 1 BOXSPRAY13
71683-004-02JO Prolonger with Benzocaine60 mL in 1 BOTTLE, SPRAYSPRAY603

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 98 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Carmex Variety Pack Classic Medicated Lip Balm Lip Balm SPF 15CAMPHOR (SYNTHETIC), WHITE PETROLATUM, OCTINOXATE, OXYBENZONECarma Laboratories, Inc.3a36a241-37a9-445a-a6e0-97709a7457a82025-03-19WarningsExact identifier
application number: M017
Herb AnalgesicHERB ANALGESIC PASTEChangsha Maocheng Trading Co., Ltd29373587-9eff-6ea0-e063-6394a90a23b22025-03-18WarningsExact identifier
application number: M017
DEBACHERE Butt Balm After Play Care Multi Symptoms ReliefBENZOCAINE, BENZALKONIUM CHLORIDEDE.BACHERE USA LLCf469b446-58a0-4be3-884f-d622b9d074f82025-03-17WarningsExact identifier
application number: M017
Auvon 4% Menthol Pain Relief GelMENTHOLSHENZHEN YUWEN E-COMMERCE CO., LTD.2dacd6fe-7d69-bcf0-e063-6294a90a03512025-03-14WarningsExact identifier
application number: M017
Eagle MedicatedMENTHOL METHYL SALICYLATEBorden Company (Private) Limited1ee49cad-84d4-42cf-aa83-c0da6f1b1b842025-03-14WarningsExact identifier
application number: M017
AY BENDITO THERMOACTIVEMENTHOL, CAMPHORAY BENDITO INTERNATIONAL, INC304d71b6-91c8-b2b6-e063-6394a90ab6692025-03-14WarningsExact identifier
application number: M017
Hot/Cold Medicated PatchHOT COLD PATCHDynarex999881b3-287e-d975-e053-2995a90a87e32025-03-14WarningsExact identifier
application number: M017
Capsaicin 0.025%CAPSAICIN 0.025%Marcella Health3054e7fd-cab2-7f77-e063-6294a90a498d2025-03-14WarningsExact identifier
application number: M017
MENTHOL 5%MENTHOL 5%Marcella Health30914c0a-fbda-5674-e063-6294a90aba5b2025-03-14WarningsExact identifier
application number: M017
Peppermint Soothing PatchCAMPHORIC ACID, MENTHOL, UNSPECIFIED FORMHenan Lijitang Medical Technology Co., Ltd.30361dd4-1f3d-ac5e-e063-6294a90a23bc2025-03-13WarningsExact identifier
application number: M017
AVCOO Menthol Pain Relief PatchMENTHOLADP Health Limited3036804b-16c3-0c88-e063-6394a90a30842025-03-13WarningsExact identifier
application number: M017
LIDOCAINE 4%LIDOCAINE 4%Marcella Health303d9462-cbfb-6251-e063-6394a90a70652025-03-13WarningsExact identifier
application number: M017
XeroBurn Burn GelLIDOCAINE HYDROCHLORIDEDynarex Corporation58985046-ca9c-12be-e053-2991aa0abe722025-03-13WarningsExact identifier
application number: M017
Post Treatment Repair CreamHYDROCORTISONEVege Labs LLC.302d4327-354b-a252-e063-6394a90a20b62025-03-12WarningsExact identifier
application number: M017
TheraCare Pain Relief 4% LidocaineLIDOCAINEVeridian Healthcare2d3fc030-5d53-2acd-e063-6294a90a11ab2025-03-11WarningsExact identifier
application number: M017
Cold Hot Medicated Patch 5% MentholMENTHOLVeridian Healthcare2d413707-794c-2fa8-e063-6394a90a06bf2025-03-11WarningsExact identifier
application number: M017
Cold Hot Medicated Patch 5% MentholMENTHOLVeridian Healthcare2d04799f-946d-ac53-e063-6294a90afeb72025-03-11WarningsExact identifier
application number: M017
Muscle and Joint CareLIDOCAINEVege Labs LLC.301966b5-b535-dc04-e063-6394a90aec172025-03-11WarningsExact identifier
application number: M017
Arctic Blast Pain ReleivingMENTHOL, CAMPHOR (SYNTHETIC)Nutriomo Labs Pte, Ltdd5e7d26d-4f63-4b7b-a173-fe3a794c84592025-03-10WarningsExact identifier
application number: M017
Anti ItchWALGREENWalgreens30014ff0-2519-4031-e063-6394a90ae07b2025-03-10WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71683-004-01716830004011 BOTTLE, SPRAY in 1 BOX (71683-004-01) / 60 mL in 1 BOTTLE, SPRAY (71683-004-02) 2015-09-030000-00-00NoNoCurrent
71683-004-027168300040260 mL in 1 BOTTLE, SPRAY60 mlHistorical