FDA.reportPublic FDA data

LavaDerm AfterSun

Product NDC
70631-067
11-digit product format
706310067
Labeler code
70631
Product ID
70631-067_4f8770bb-310d-48d9-e063-6294a90afcdb
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
SPRAY
Route
TOPICAL
Labeler
Young Living Essential Oils, LC.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-04-18
Substance
MENTHOL
Active strength
.5 g/100g
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
LavaDerm AfterSun
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL.5 g/100g

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
1314935Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4fcddcf1-36db-2f1a-e054-00144ff8d46cAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70631-067-57LavaDerm AfterSun1 in 1 BOXSPRAY14
70631-067-57LavaDerm AfterSun57 g in 1 BOTTLE, SPRAYSPRAY574

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 140 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Westlake Anti-itchHYDROCORTISONEWestlake Pharma LLC0c53c982-3f23-a2d5-e063-6394a90acd552023-12-12WarningsExact identifier
application number: M017
Rite Aid Anti-itchHYDROCORTISONERite Aid0c540422-1579-9217-e063-6294a90ad06a2023-12-12WarningsExact identifier
application number: M017
Anti-itch Paraben FreeHYDROCORTISONEWeeks & Leo Co., Inc.0c5419c5-0929-7ca6-e063-6294a90ac0a72023-12-12WarningsExact identifier
application number: M017
Rite Aid HydrocortisoneHYDROCORTISONE 1%Rite Aid0c580f96-7fe9-19df-e063-6394a90a5a222023-12-12WarningsExact identifier
application number: M017
Anti itchHYDROCORTISONEWeeks & Leo Co., Inc.0c58b750-d3a6-5ed1-e063-6294a90a43212023-12-12WarningsExact identifier
application number: M017
Greencaine BlastLIDOCAINEALMA Laboratories, Inc.031e0065-4c8a-43d8-bc69-3efa3c6c0ae32023-12-12WarningsExact identifier
application number: M017
Ageless Pain ReliefMETHYL SALICYLATE, MENTHOLIsagenix International, LLC3c7e493b-923d-44b1-9076-46c7894308d42023-12-12Warnings, Adverse reactionsExact identifier
application number: M017
CVS Extra Strength Itch StoppingDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATECVS857af609-9dd7-a07a-e053-2991aa0ab6ba2023-12-11WarningsExact identifier
application number: M017
Rite Aid Extra Strength Itch StoppingDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATERite Aid0c4170dd-e1fa-d549-e063-6394a90a5c232023-12-11WarningsExact identifier
application number: M017
Westlake Itch ReliefDIPHENHYDRAMINE HCL, ZINC ACETATEWestlake HB Pharma LLC0c416ba6-b01f-0609-e063-6294a90ae2a12023-12-11WarningsExact identifier
application number: M017
CVS Regular Strength Itch StoppingDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATECVS87473ace-d834-e43f-e053-2a95a90a819c2023-12-11WarningsExact identifier
application number: M017
Katinko External Analgesic OilCAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATEGreenstone Pharmaceutical Inc.5881fc35-3293-4f0b-801a-afcd6feb94962023-12-08WarningsExact identifier
application number: M017
Katinko Pain And Itch RelievingCAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATEGreenstone Pharmaceutical Inc.fe907fa4-4a01-4974-b71f-9cd980b4eaa22023-12-08Warnings, Adverse reactionsExact identifier
application number: M017
CycleMENTHOLLa Mend, Inc.cfc0bcde-ef91-1e6c-e053-2a95a90ab79e2023-12-07WarningsExact identifier
application number: M017
Hemorrhoidal Pain Relief CreamGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMWALGREENS03bbe146-f185-bcfa-e063-6394a90a85bf2023-12-04WarningsExact identifier
application number: M017
Quatriderm Anti-itchHYDROCORTISONEOPMX LLC83e59e10-9878-e5c2-e053-2a91aa0af25e2023-12-04WarningsExact identifier
application number: M017
TACTDIPHENHYDRAMINE HYDROCHLORIDE, MENTHOLSato Pharmaceutical Inc., Ltd.b6e2ee24-69de-4dfd-9081-b9537b7a7bad2023-12-04WarningsExact identifier
application number: M017
Overnight Cold Therapy Pain ReliefMENTHOL, UNSPECIFIED FORMWalgreen Co.2cbd0966-4cf9-4271-bd53-6672b1ed2a992023-12-04WarningsExact identifier
application number: M017
Prolayed Lidocaine Male Genital DesensitizerLIDOCAINEViaDerma Distribution, Inc.9c5ad0d0-ca7a-4321-9334-f06f3f6be18f2023-12-02WarningsExact identifier
application number: M017
Liberdol Topical AnalgesicMETHYL SALICYLATE, MENTHOL, CAMPHOR (SYNTHETIC)ViaDerma Distribution, Incab52cd0e-34fa-41c7-9ce7-1183c2aff8d82023-12-01WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1314935menthol 0.5 % Topical SprayPSN4fcddcf1-36db-2f1a-e054-00144ff8d46c4
1314935menthol 5 MG/ML Topical SpraySCD4fcddcf1-36db-2f1a-e054-00144ff8d46c4
1314935menthol 0.5 % Topical SpraySY4fcddcf1-36db-2f1a-e054-00144ff8d46c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70631-067-57706310067571 BOTTLE, SPRAY in 1 BOX (70631-067-57) / 57 g in 1 BOTTLE, SPRAY2024-04-18NoNoCurrent