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 41 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Maximum Strength Hydrocortisone Cream with AloeHYDROCORTISONE CREAMWalgreense8f69c4b-2570-477e-9c6d-d552d30ac0d02026-01-14WarningsExact identifier
application number: M017
HydrocortisoneCOOL RELIEF GEL WITH ALOEWalgreens1ae2b37d-d5b2-74d2-e063-6294a90a0de02026-01-14WarningsExact identifier
application number: M017
Maximum Strength Cortisone Cream with AloeHYDROCORTISONE CREAMCVS Pharmacyb95d30b0-6ebd-4989-a6ac-1a42e5d4aba52026-01-14WarningsExact identifier
application number: M017
Maximum Strength Hydrocortisone Cream with AloeHYDROCORTISONE CREAMWalgreens61b93226-10ff-43df-b1b6-bcea917a2f482026-01-14WarningsExact identifier
application number: M017
Maximum Strength Hydrocortisone CreamHYDROCORTISONE CREAMWalgreens2112067c-0fbb-400c-9923-b932946e1a122026-01-14WarningsExact identifier
application number: M017
Maximum Strength Hydrocortisone CreamHYDROCORTISONE CREAMWalgreensa7db0a6f-ceca-4e77-bad7-55c3c74413a72026-01-14WarningsExact identifier
application number: M017
CVS Therapeutic Menthol GelMENTHOLCVS Pharmacya02605cd-40d1-4ea1-9828-0695f2d123aa2026-01-14WarningsExact identifier
application number: M017
Maximum Strength CortisoneHYDROCORTISONE OINTMENTCVS Pharmacyf25f2e14-4fc9-4c92-880d-e5f9279d4ecd2026-01-14WarningsExact identifier
application number: M017
Icy Hot with Lidocaine No-MessMENTHOL AND LIDOCAINEChattem, Inc.a2803c07-bf39-4028-9262-5082da25b46e2026-01-14WarningsExact identifier
application number: M017
Cortisone 10 Intensive Moisture CremeHYDROCORTISONEChattem, Inc.096a9af3-7e7c-4dae-bc22-44061c60d3c92026-01-14WarningsExact identifier
application number: M017
Icy Hot DryMENTHOLChattem, Inc.720a85cc-8e98-43f2-9cc8-5636ae09624f2026-01-14WarningsExact identifier
application number: M017
Gold Bond Extra StrengthMENTHOLChattem, Inc.98ea15e6-972f-44a3-a1e4-abeae538d5a72026-01-14WarningsExact identifier
application number: M017
Timing Pain Savior Fragrant Ginger PatchMENTHOL, METHYL SALICYLATETiming Pharmaceutical Co., Ltd PABP Brancha0308e0e-1b47-42ab-88ac-b71ff3fa6c472026-01-14WarningsExact identifier
application number: M017
Cortizone 10 Easy ReliefHYDROCORTISONEChattem, Inc.beb73818-cd88-44ff-8ecd-b02b910b53b72026-01-14WarningsExact identifier
application number: M017
diphenhydramine hcl and zinc acetateDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATEPadagis Israel Pharmaceuticals Ltd6d7a7615-9ae7-4c55-8a84-dba746f535d72026-01-14WarningsExact identifier
application number: M017
Timing Pain Savior Cool Herbal PatchMENTHOL, METHYL SALICYLATETiming Pharmaceutical Co., Ltd PABP Branch3b260be8-5e2a-4fba-85d6-2e6c64b970762026-01-14WarningsExact identifier
application number: M017
Cortizone 10 Feminine Itch ReliefHYDROCORTISONEChattem, Inc.c0c0c1fb-43c9-4903-bb3b-f0885619b8cc2026-01-14WarningsExact identifier
application number: M017
Icy Hot Pro Pain Relief Cream w/ microbeadsMENTHOL, CAMPHORChattem, Inc.df5fd485-f583-46b7-a869-16ca2e17185c2026-01-14WarningsExact identifier
application number: M017
Cortizone 10 Ultra Soothing CremeHYDROCORTISONEChattem, Inc.4b62615f-e713-42f2-8b9c-9eebf8d1b2702026-01-14WarningsExact identifier
application number: M017
Gold Bond Medicated Pain and Itch ReliefLIDOCAINE HYDROCHLORIDEChattem, Inc.5767362c-83af-494e-a815-a13f2cb093ef2026-01-14WarningsExact 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