FDA.reportPublic FDA data

Outgro

Product NDC
63029-531
11-digit product format
630290531
Labeler code
63029
Product ID
63029-531_43f87627-6147-4dc2-b4cf-1994fbfb1067
Type
HUMAN OTC DRUG
Nonproprietary name
Benzocaine
Dosage form
LIQUID
Route
TOPICAL
Labeler
Medtech Products Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-01-01
Substance
BENZOCAINE
Active strength
18.6 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
2027-12-31
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
Outgro
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOCAINE18.6 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
d6be8a1d-aca7-42b1-86da-881d42ffe8d5Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63029-531-11Outgro9 mL in 1 BOTTLE, WITH APPLICATORLIQUID95
63029-531-11Outgro1 in 1 BOXLIQUID15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZOCAINEACTIVE INGREDIENTU3RSY48JW5OUTGRO (BENZOCAINE) LIQUID [MEDTECH PRODUCTS INC.]2
BENZOCAINEACTIVE MOIETYU3RSY48JW5OUTGRO (BENZOCAINE) LIQUID [MEDTECH PRODUCTS INC.]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MOUTGRO (BENZOCAINE) LIQUID [MEDTECH PRODUCTS INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GOUTGRO (BENZOCAINE) LIQUID [MEDTECH PRODUCTS INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDOUTGRO (BENZOCAINE) LIQUID [MEDTECH PRODUCTS INC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAOUTGRO (BENZOCAINE) LIQUID [MEDTECH PRODUCTS INC.]2
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQOUTGRO (BENZOCAINE) LIQUID [MEDTECH PRODUCTS INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63029-531OUTGRO (BENZOCAINE) LIQUID [MEDTECH PRODUCTS INC.]5Current NDC, Legacy NDC, 2 package rows20241215_d6be8a1d-aca7-42b1-86da-881d42ffe8d5.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 34 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tiger Balm Active Muscle RubMETHYL SALICYLATE, MENTHOL, UNSPECIFIED FORM, AND CAMPHOR (SYNTHETIC)Haw Par Healthcare Ltd.2e7638c6-e1ce-4e2f-bd50-52fbce5a138e2026-02-09WarningsExact identifier
application number: M017
Tiger Balm Neck and Shoulder RubCAMPHOR (SYNTHETIC) AND MENTHOLHaw Par Healthcare Ltd.2f272d12-7b34-430e-817e-1005f57ed9e92026-02-09WarningsExact identifier
application number: M017
Welmate Lidocaine Pain Relieving PatchLIDOCAINEYYBA CORP4303fd30-0d35-3671-e063-6394a90a2aee2026-02-09WarningsExact identifier
application number: M017
Pain Relief LidocaineLIDOCAINEKroger Company4098756e-3d9f-317a-e063-6394a90af04c2026-02-09WarningsExact identifier
application number: M017
Aquanil HCHYDROCORTISONEPerson and Covey4a698246-05a6-d01f-e063-6294a90a34012026-02-09WarningsExact identifier
application number: M017
Hemorrhoid MasterLIDOCAINE, PHENYLEPHRINEEbanel Laboratories, Inc41292d65-dabe-4bc3-872f-34a3912aa3422026-02-09WarningsExact identifier
application number: M017
DERMFREE NEUROPATHYARNICA MONTANA 1X HPUS 7% NEUROPATHYJiangxi Yudexi Pharmaceutical Co., LTD4a5c232d-5d29-2504-e063-6394a90ac9de2026-02-08WarningsExact identifier
application number: M017
ASSIELF NUMBING Topical AnorectalLIDOCAINEShenzhen Yuanbang International Logistics Co., Ltd4a5cb477-57ef-2a1d-e063-6394a90ac9ed2026-02-08WarningsExact identifier
application number: M017
Lidocaine Pain Relieve Gel-PatchPAIN RELIEVE GEL-PATCHHenan Kangdi Medical Devices Co., Ltd1e31b950-e990-e255-e063-6394a90a7d232026-02-07WarningsExact identifier
application number: M017
Herbal Knee PatchHERBAL KNEE PATCHHenan Kangdi Medical Devices Co., Ltd2a009059-b515-8214-e063-6294a90a4ed32026-02-07WarningsExact identifier
application number: M017
Flocean ANTI-ITCHBENZOCAINE 5%ANTI-ITCHJiangxi Yudexi Pharmaceutical Co., LTD4a493911-a846-5aa0-e063-6294a90a65ac2026-02-07WarningsExact identifier
application number: M017
daily solutions Ice Blue AnalgesicMENTHOL, UNSPECIFIED FORMGarcoa, Inc.4d8c8c14-ecaa-43de-a07f-c73ca0d1e3e62026-02-06WarningsExact identifier
application number: M017
Lidocaine Pain Relief Gel-PatchLIDOCAINEShenzhen Wankelai E-commerce Co., Ltd.4a22562b-601e-97d7-e063-6394a90a5bca2026-02-06WarningsExact identifier
application number: M017
hydrocortisoneHYDROCORTISONESportpharm LLCee64ad1e-78db-4553-a3cf-b539b770fa262026-02-06WarningsExact identifier
application number: M017
Pain Relief Gel-PatchLIDOCAINE 4%Sportpharm LLC1dd022b9-88ae-4737-88cc-fdb0ce0a83a32026-02-06WarningsExact identifier
application number: M017
Camphor plus Lidocaine Pain ReliefCAMPHOR, LIDOCAINEVeridian Healthcare4a2b73a8-c10c-85f9-e063-6294a90ac52c2026-02-06WarningsExact identifier
application number: M017
Aloe Vera GelLIDOCAINE HCL, MENTHOLRetail Business Services, LLC073c72fe-3171-4a4f-913a-d1b9630a1af32026-02-06Warnings, Adverse reactionsExact identifier
application number: M017
HealthWise Soothing Lidocaine Pain ReliefLIDOCAINE HCI 0.5%Veridian Healthcare4a2ec73e-7332-6f13-e063-6294a90a85062026-02-06WarningsExact identifier
application number: M017
5 Elementum Delay WipesBENZOCAINE DELAY WIPESMSVenturesGroup O440539b0-612b-3b41-e063-6294a90a1ddd2026-02-05WarningsExact identifier
application number: M017
COOLING PAIN RELIEFMENTHOL, CAMPHORCHEMCO CORPORATION4a156400-7001-d00d-e063-6294a90aa7142026-02-05WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63029-531-11630290531111 BOTTLE, WITH APPLICATOR in 1 BOX (63029-531-11) / 9 mL in 1 BOTTLE, WITH APPLICATOR2013-01-010000-00-00NoNoCurrent