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

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 Identifiers#

Field, Values table
FieldValues
UniiU3RSY48JW5

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

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