Soltice

Product NDC
45728-100
11-digit product format
457280100
Labeler code
45728
Product ID
45728-100_5c404882-9de9-659a-e063-6394a90affb0
Type
HUMAN OTC DRUG
Nonproprietary name
menthol, camphor
Dosage form
CREAM
Route
TOPICAL
Labeler
Oakhurst Company
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-09-09
Substance
MENTHOL; CAMPHOR (NATURAL)
Active strength
.051; .051 g/g; g/g
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
Soltice
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL.051 g/g
CAMPHOR (NATURAL).051 g/g

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 81 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MedPride Medicated Body Powder PowderMENTHOL, ZINC OXIDEShield Line LLCcdb2fa5b-cf04-c876-e053-2a95a90a187c2025-08-15WarningsExact identifier
application number: M017
BurnLIDOCAINEHART Healthc5ff392a-e788-43e0-91ea-5e0f8420586c2025-08-15WarningsExact identifier
application number: M017
Stopain ClinicalMENTHOLTroy Manufacturing, Inc.40df30ba-41ba-42b7-93fe-4183b57bdb002025-08-14WarningsExact identifier
application number: M017
Signature Care Aloe Vera Gel with LidocaineLIDOCAINESafeway, Inc.d5069622-97b1-ba12-e053-2a95a90a72682025-08-14WarningsExact identifier
application number: M017
METHYL SALICYLATE 25%METHYL SALICYLATEOncora Pharma, LLC3c4bc55d-6582-3b5e-e063-6394a90a994c2025-08-13WarningsExact identifier
application number: M017
Lidocaine 3%LIDOCAINE HCL 3%PureTek Corporation3bc94d52-fe52-9fd6-e063-6294a90a43402025-08-12WarningsExact identifier
application number: M017
Fast FreezeMENTHOLNatural Essentials Inc.d8c42c8d-6ce0-43bf-b165-41979f3d8f792025-08-12WarningsExact identifier
application number: M017
Careland X-large Lidocaine 4 Pain RelievingLIDOCAINEPlanet (Anhui) Pharmaceutical Co., Ltd.a6867506-4a46-47b1-b5b6-bfedb59dfde62025-08-11WarningsExact identifier
application number: M017
Dermedial Anti-OuchMENTHOLSaje Natural Business Inc.3c194b8f-cfa5-11e3-e063-6394a90a92de2025-08-11WarningsExact identifier
application number: M017
Thera Plus Extra Strength Muscle Rub Topical AnalgesicMENTHOLFOURSTAR GROUP USA, INC.8a3b6adf-afbb-4d77-a19b-a6514ebd3b502025-08-11WarningsExact identifier
application number: M017
EARTHS CARE ARTHRITISCAPSAICINDLC Laboratories, Inc.9460674b-057e-40b9-a0f9-ca3d92068d4f2025-08-11WarningsExact identifier
application number: M017
LILAS PERIODMENTHOLLilas Wellness, Inc.5ea53b4b-45e6-48a7-8090-09c3a21e7f632025-08-11WarningsExact identifier
application number: M017
Lidocaine Pain Relief Gel Roll-OnLIDOCAINEGuangzhou Zhupuyou E-commerce Co., Ltd31639407-0f11-bde2-e063-6294a90af6942025-08-10WarningsExact identifier
application number: M017
Chinese Red Tiger Lidocaine PatchesLIDOCAINEGuangzhou Zhupuyou E-commerce Co., Ltd20cd369c-3e98-3d8f-e063-6394a90a08242025-08-10WarningsExact identifier
application number: M017
Treatonic LIDOCAINE PAIN RELIEFLIDOCAINE 4%100 KARMA INC3bd66b03-ac82-2d45-e063-6294a90a610a2025-08-08WarningsExact identifier
application number: M017
Capsaicin 0.025%CAPSAICIN 0.025%Advanced Rx of Tennessee, LLC3bdcef94-d06f-9152-e063-6294a90a60722025-08-08WarningsExact identifier
application number: M017
MENTHOL 5%MENTHOL 5%Advanced Rx of Tennessee, LLC3bdd0c52-29d8-ab67-e063-6294a90a9c452025-08-08WarningsExact identifier
application number: M017
Methyl Salicylate 25% CreamMETHYL SALICYLATEAdvanced Rx of Tennessee, LLC3bdd3015-349a-0fac-e063-6394a90afe412025-08-08WarningsExact identifier
application number: M017
LIDOCAINE 4%LIDOCAINE 4%Advanced Rx of Tennessee, LLC3bdd6b3d-7180-288c-e063-6394a90a17852025-08-08WarningsExact identifier
application number: M017
Good Sense Pain Relief Roll OnLIDOCAINE HCLGeiss, Destin & Dunn, Inc38e76fd6-e5fb-493c-e063-6294a90afed42025-08-08WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
45728-100-01457280100011 JAR in 1 CARTON (45728-100-01) / 37 g in 1 JAR1 jar2026-09-09NoNoCurrent
45728-100-03457280100031 JAR in 1 CARTON (45728-100-03) / 85 g in 1 JAR1 jar2026-09-09NoNoCurrent