Dermedial Anti-Ouch

Product NDC
70983-030
11-digit product format
709830030
Labeler code
70983
Product ID
70983-030_3c194ba4-f587-682c-e063-6294a90a0b9d
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Saje Natural Business Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-06-30
Substance
MENTHOL
Active strength
12.7 mg/g
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
Dermedial Anti-Ouch
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL12.7 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L7T10EIP3AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1813422Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3c194b8f-cfa5-11e3-e063-6394a90a92deAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70983-030-01Dermedial Anti-Ouch1 in 1 BOXOINTMENT11
70983-030-01Dermedial Anti-Ouch54.1 g in 1 CANISTEROINTMENT54.11
70983-030-02Dermedial Anti-Ouch13.5 g in 1 CANISTEROINTMENT13.51

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 124 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Wegmans Aloe After Sun Gel with Lidocaine HCl External AnalgesicLIDOCAINE HYDROCHLORIDEWEGMANS FOOD MARKETS INCf70bc438-7ed8-f74d-e053-6394a90a2b3f2024-10-16WarningsExact identifier
application number: M017
EQUATE Sunburn relief with Aloe After SunLIDOCAINEWal-Mart Stores Incc25e1288-7ac6-41fc-ab65-26c379f288a72024-10-16WarningsExact identifier
application number: M017
Genuine First Aid Insect Sting Relief Pad 1 ctBENZOCAINE, ALCOHOLGFA Production (Xiamen) Co., Ltd.b119ba37-0ee1-851a-e053-2995a90a85b12024-10-15WarningsExact identifier
application number: M017
PAIN RELIEF PATCHESLIDOCAINEWalgreen Company1a587e6e-88d1-4b01-abad-9a365dc64a4d2024-10-15WarningsExact identifier
application number: M017
TopCare Everyday After Sun CoolingLIDOCAINE HYDROCHLORIDETOPCO ASSOCIATES LLCbaff7293-e1a3-d1f2-e053-2995a90a93ca2024-10-15WarningsExact identifier
application number: M017
Universal PAIN RELIEFLIDOCAINEUniversal Distribution Center LLCb132a4f2-1b1f-4e80-a183-f9add449065f2024-10-14WarningsExact identifier
application number: M017
Nervex Pain RelievingCAPSAICINVITA SCIENCES, LLCa39bba22-8c54-4252-9973-052dd2aaea362024-10-14WarningsExact identifier
application number: M017
CVS Health Lidocaine Pain-RelievingLIDOCAINENATURAL ESSENTIALS, INC.d07fdffd-bf7c-4950-9b2d-c06d54ef4c552024-10-14WarningsExact identifier
application number: M017
Walgreens CoolingLIDOCAINE HYDROCHLORIDEWALGREEN COMPANYbaffb272-436c-4ad8-e053-2a95a90a56fb2024-10-14WarningsExact identifier
application number: M017
Walgreens Sunburn ReliefMENTHOLWALGREEN COMPANYc8967fba-6c28-494b-e053-2995a90acbba2024-10-14WarningsExact identifier
application number: M017
Walgreens Sunburn ReliefLIDOCAINEWALGREEN COMPANYd5067903-c559-dc6d-e053-2995a90a8ee32024-10-14WarningsExact identifier
application number: M017
Diphenhydramine HCl and Zinc AcetateEXTRA STRENGTH ITCH RELIEFMeijer Distribution Inc18998e1c-1254-4d0c-93f1-26652c5ca0762024-10-14WarningsExact identifier
application number: M017
signature care itch reliefDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATESafeway3eedcd9f-8312-4d14-a0fe-6b00a00d3e732024-10-13WarningsExact identifier
application number: M017
itch reliefDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATEH E B34c7bcd3-203f-4630-894d-3739a1576c8d2024-10-13WarningsExact identifier
application number: M017
hydrocortisoneHYDROCORTISONEH E B25ec9014-64c4-44df-9e67-9f9223ffc9232024-10-12WarningsExact identifier
application number: M017
PAIN RELIEF Gel-Roll OnLIDOCAINE AND MENTHOLShanghai Chuangshi Medical Technology (Group) Co., Ltd.f02fa9c0-b8af-f362-e053-2a95a90ae5162024-10-11WarningsExact identifier
application number: M017
Insect Sting Relief PadBENZOCAINE, ALCOHOLHubei Changjian Medical Products Co., Ltd.6a269982-0e25-4c09-aef1-0b398bdc5ed42024-10-11WarningsExact identifier
application number: M017
HYDROCORTISONEHYDROCORTISONEVIVE HEALTH LLC24221805-e5c9-5785-e063-6394a90a9d2f2024-10-10WarningsExact identifier
application number: M017
De La Cruz CamphorCAMPHORDLC Laboratories, Inc.62359237-de2d-4497-bfd6-36991cfc8acf2024-10-10WarningsExact identifier
application number: M017
Anti ItchDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATEMeijer Distribution Inc4f536a86-6419-4ab0-a7e8-5c37943823e22024-10-09WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1813422menthol 1.27 % Topical OintmentPSN3c194b8f-cfa5-11e3-e063-6394a90a92de1
1813422menthol 0.0127 MG/MG Topical OintmentSCD3c194b8f-cfa5-11e3-e063-6394a90a92de1
1813422menthol 1.27 % Topical OintmentSY3c194b8f-cfa5-11e3-e063-6394a90a92de1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70983-030-01709830030011 CANISTER in 1 BOX (70983-030-01) / 54.1 g in 1 CANISTER1 canister2025-06-30NoNoCurrent
70983-030-027098300300213.5 g in 1 CANISTER (70983-030-02) 13.5 g2025-06-30NoNoCurrent