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 133 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pain Relief MuscleCAMPHOR (NATURAL)J.R. Watkins, LLC.1dc21c95-b419-4175-85f8-040b73060d372024-03-20WarningsExact identifier
application number: M017
Pain Relief Roll-On MuscleCAMPHOR (NATURAL)J.R. Watkins, LLC.d94ae654-ce25-4bff-b9bd-24a0e0e8568a2024-03-20WarningsExact identifier
application number: M017
Pain Relief MuscleCAMPHOR (NATURAL)J.R. Watkins, LLC.f8bff018-fb4f-47b4-b8f8-4a496aede3462024-03-20WarningsExact identifier
application number: M017
Rugby Arthritis Pain Relieving Topical AnalgesicCAPSAICINRugby Laboratories8f1bc075-97ac-4154-8768-0d878104c3ba2024-03-14WarningsExact identifier
application number: M017
Rugby Ice Blue External AnalgesicMENTHOL, UNSPECIFIED FORMRugby Laboratories2b65cb6a-4364-4770-b7b9-5c4637edd01a2024-03-14WarningsExact identifier
application number: M017
Leader Cooling Pain Relief Topical AnalgesicMENTHOL, UNSPECIFIED FORMCardinal Health, 110 dba LEADERfd06d17f-4dff-42a9-a84f-904809ceb9812024-03-13WarningsExact identifier
application number: M017
MENTHOL, CAMPHORMENTHOL, CAMPHOREROS GLOBALb3495c95-ba4b-9459-e053-2a95a90a710f2024-03-12WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONETRIFECTA PHARMACEUTICALS USA LLC1369e70f-7a61-7078-e063-6394a90a9a882024-03-11WarningsExact identifier
application number: M017
Pain Reliever CreamMENTHOL 10%, METHYL SALICYLATE 15%Trifecta Pharmaceuticals USA, LLC.130665d6-3de8-cb91-e063-6294a90a20832024-03-06WarningsExact identifier
application number: M017
Dermachange Aid Anti-ItchDIPHENHYDRAMINE HCLPrivate Label Beauty and Wellness12ed906c-d028-0ff7-e063-6394a90aaa522024-03-05WarningsExact identifier
application number: M017
Dermachange Cold TherapyMENTHOLPrivate Label Beauty and Wellness12ef7dd8-3da3-9c87-e063-6394a90ac9242024-03-05WarningsExact identifier
application number: M017
Dermachange Arthritis ReliefTROLAMIN SALICYLATEPrivate Beauty Label and Wellness12dbfa50-1b97-f988-e063-6394a90a662c2024-03-04WarningsExact identifier
application number: M017
AnalgesicMENTHOLSafetec of America, Inc.b0f4010c-995f-40e1-aa40-92760e697a612024-03-02WarningsExact identifier
application number: M017
Icy Hot Advanced ReliefCAMPHOR AND MENTHOLChattem, Inc.9979ff36-415b-44e4-bb10-6bf682cd00f92024-03-01WarningsExact identifier
application number: M017
Amish Origins Pain Relieving Menthol 8%MENTHOLAmish Origins Management, LLC5051b650-18a4-481e-a8d7-d41d4ae51efd2024-02-29WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONETRIFECTA PHARMACEUTICALS USA LLC2999fecb-cb15-4023-ade4-ab5822b094d52024-02-29WarningsExact identifier
application number: M017
Amish Origins Pain Relieving Menthol 8MENTHOLAmish Origins Management, LLCaaad56d5-6737-4edc-af0e-8e207695c0ec2024-02-29WarningsExact identifier
application number: M017
Amish Origins Pain Relieving Menthol 8%MENTHOLAmish Origins Management, LLCb120404f-5a07-4182-bb50-d943418622da2024-02-29WarningsExact identifier
application number: M017
Amish Origins Topical Analgesic Camphor 2%CAMPHOR (SYNTHETIC)Amish Origins Management, LLC437491ca-60ff-4508-b408-f97e7152f6382024-02-29WarningsExact identifier
application number: M017
Amish Origins Topical Analgesic Camphor 2%CAMPHOR (SYNTHETIC)Amish Origins Management, LLCffe15aed-ea90-4db8-aace-d691a81c05ae2024-02-29WarningsExact 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