STA-HARD

Product NDC
83608-102
11-digit product format
836080102
Labeler code
83608
Product ID
83608-102_434a875b-2593-3b30-e063-6294a90a9518
Type
HUMAN OTC DRUG
Nonproprietary name
Desensitizing Lubricant
Dosage form
CREAM
Route
TOPICAL
Labeler
Novelties by Nasswalk, Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-08-07
Substance
BENZOCAINE
Active strength
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

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
STA-HARD
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOCAINE5 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
02ef794b-8e70-5c26-e063-6294a90a28d1Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83608-102-02STA-HARD0.5 mL in 1 TUBECREAM0.53
83608-102-02STA-HARD1 in 1 CARTONCREAM13
83608-102-05STA-HARD0.5 mL in 1 TUBECREAM0.53
83608-102-05STA-HARD1 in 1 CARTONCREAM13
83608-102-15STA-HARD1.5 mL in 1 TUBECREAM1.53
83608-102-15STA-HARD1 in 1 CARTONCREAM13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83608-102STA-HARD (DESENSITIZING LUBRICANT) CREAM [NOVELTIES BY NASSWALK, INC.]2Current NDC, 6 package rows20241123_02ef794b-8e70-5c26-e063-6294a90a28d1.zip

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 132 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eagle Brand Medicated Oil AromaticCAMPHOR, MENTHOL, METHYL SALICYLATEBorden Company (Private) Limited0e808f89-62dc-3790-e063-6394a90a23512024-05-13WarningsExact identifier
application number: M017
Walgreens Lidocaine Plus CreamBENZYL ALCOHOL AND LIDOCAINE HYDROCHLORIDEWalgreens Companye33e0097-31d6-8083-e053-2a95a90af5d22024-05-09WarningsExact identifier
application number: M017
Professional Therapy MuscleCare Pro Pain Relieving Cold GelCAMPHOR, MENTHOLACTIVE AND INNOVATIVE, LLC1794c512-5f42-4ec3-e063-6394a90a87cd2024-05-03WarningsExact identifier
application number: M017
Professional Therapy MuscleCare ProMENTHOL AND CAMPHORACTIVE AND INNOVATIVE, LLC17961a84-6bee-c75f-e063-6394a90af5762024-05-03WarningsExact identifier
application number: M017
Aspercreme with Lidocaine Pain Relieving CremeLIDOCAINE HYDROCHLORIDEChattem, Inc.d5da67c3-c2ec-4e3e-abe9-cc862dcfc8bd2024-05-01WarningsExact identifier
application number: M017
Lidocaine HCl 4 PercentLIDOCAINE HYDROCHLORIDEARI BRANDS, LLC81aff5c5-91c0-4173-a432-d201156135802024-04-30WarningsExact identifier
application number: M017
HealthWise 3x Medicated Pain Relief Patch 120 BulkCAMPHOR,MENTHOL, METHYL SALICYLATEVeridian Healthcare17545078-05e1-9338-e063-6394a90a678c2024-04-30WarningsExact identifier
application number: M017
Professional Therapy MuscleCare Pro Roll-onCAMPHOR, MENTHOLACTIVE AND INNOVATIVE, LLC1755ec89-c404-1c17-e063-6394a90ab9fb2024-04-30WarningsExact identifier
application number: M017
PAIN RELIEF Gel-Roll OnMENTHOLShanghai Chuangshi Medical Technology (Group) Co., Ltd.f0bc2a14-6bda-428c-e053-2995a90a4ced2024-04-29WarningsExact identifier
application number: M017
PAIN RELIEF Gel-TubeMENTHOLShanghai Chuangshi Medical Technology (Group) Co., Ltd.f0bec1d4-2e18-4519-e053-2a95a90a1bbb2024-04-29WarningsExact identifier
application number: M017
THERAPLEX AIM Anti-Itch MoisturizingHYDROCORTISONETHERAPLEX, LLCd1b231b6-cc9f-488a-9121-5018314737722024-04-27WarningsExact identifier
application number: M017
HYDROCORTISONEHYDROCORTISONE ACETATEJHK Inc dba American Safety & First Aid64adc8d0-7ca4-4c1a-813f-f1df47e916f22024-04-25WarningsExact identifier
application number: M017
HealthWise Lidocaine Plus CreamBENZYL ALCOHOL, LIDOCAINE HYDROCHLORIDEVeridian Healthcare16f26249-b508-2c6e-e063-6394a90a265b2024-04-25WarningsExact identifier
application number: M017
Hydrocortisone Cream with AloeHYDROCORTISONECardinal Health 110 dba LEADER16f2f3cb-4611-5867-e063-6394a90af1072024-04-25WarningsExact identifier
application number: M017
BurnLIDOCAINE HYDROCHLORIDEJHK Inc5a4ac4cc-015a-48e7-81f8-93a895049afd2024-04-25WarningsExact identifier
application number: M017
Cold Therapy Pain ReliefMENTHOL, UNSPECIFIED FORMWalgreen Co.ede15818-5d17-477d-a8be-7b36bb0770a62024-04-22WarningsExact identifier
application number: M017
Anti ItchHYDROCORTISONENeilmed Pharmaceuticals Inc.14b4f066-fde4-ac97-e063-6394a90ae64c2024-04-20WarningsExact identifier
application number: M017
Walgreens Cold Therapy Pain Relief PatchMENTHOL 5%Walgreens Companye33c90d1-2729-970f-e053-2995a90ad97a2024-04-18WarningsExact identifier
application number: M017
HealthWise Cold Therapy Pain Relief PatchMENTHOLVeridian Healthcare0ce356e0-90a3-ad52-e063-6294a90a404a2024-04-18WarningsExact identifier
application number: M017
Walgreens Scalp Relief External analgesicHYDROCORTISONEWalgreen Companyda0a24c7-9295-4f22-b2c7-40000dad4b812024-04-18WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83608-102-02836080102021 TUBE in 1 CARTON (83608-102-02) / .5 mL in 1 TUBE1 tube2023-08-07NoNoCurrent
83608-102-05836080102051 TUBE in 1 CARTON (83608-102-05) / .5 mL in 1 TUBE1 tube2023-08-07NoNoCurrent
83608-102-15836080102151 TUBE in 1 CARTON (83608-102-15) / 1.5 mL in 1 TUBE1 tube2023-08-07NoNoCurrent