FDA.reportPublic FDA data

Reed Therapeutics Pain Relieving Therapy

Product NDC
76437-609
11-digit product format
764370609
Labeler code
76437
Product ID
76437-609_f1f6551d-a099-427f-a223-79a6151523ee
Type
HUMAN OTC DRUG
Nonproprietary name
Methyl Salicylate, Menthol USP, Camphor
Dosage form
GEL
Route
TOPICAL
Labeler
Reed Therapeutics
Application
part356
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2013-03-29
Marketing end
0000-00-00
Substance
METHYL SALICYLATE; MENTHOL; CAMPHOR (SYNTHETIC)
Active strength
13 g/100g; g/100g; g/100g
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76437-609-032019-11-27C16284748780-19855d018-d454-cd31-e053-dbdaa90ab51aReed Therapeutics Pain Relieving Therapy
76437-609-052019-11-27C16284748780-19855d018-d2cb-cd31-e053-dbdaa90ab51aReed Therapeutics Pain Relieving Therapy
76437-609-162019-11-27C16284748780-19855d018-d742-cd31-e053-dbdaa90ab51aReed Therapeutics Pain Relieving Therapy

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76437-609-05Reed Therapeutics Pain Relieving Therapy150 g in 1 TUBEGEL1502
76437-609-16Reed Therapeutics Pain Relieving Therapy454 g in 1 BOTTLE, PUMPGEL4542
76437-609-03Reed Therapeutics Pain Relieving Therapy87 g in 1 CANISTERGEL871

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CAMPHOR (SYNTHETIC)ACTIVE INGREDIENT5TJD82A1ETREED THERAPEUTICS PAIN RELIEVING THERAPY (METHYL SALICYLATE, MENTHOL USP, CAMPHOR) GEL [REED THERAPEUTICS]2
CAMPHOR (SYNTHETIC)ACTIVE INGREDIENT5TJD82A1ETREED THERAPEUTICS PAIN RELIEVING THERAPY (METHYL SALICYLATE, MENTHOL USP, CAMPHOR) GEL [REED THERAPEUTICS]2
MENTHOLACTIVE INGREDIENTL7T10EIP3AREED THERAPEUTICS PAIN RELIEVING THERAPY (METHYL SALICYLATE, MENTHOL USP, CAMPHOR) GEL [REED THERAPEUTICS]2
MENTHOLACTIVE INGREDIENTL7T10EIP3AREED THERAPEUTICS PAIN RELIEVING THERAPY (METHYL SALICYLATE, MENTHOL USP, CAMPHOR) GEL [REED THERAPEUTICS]2
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022YREED THERAPEUTICS PAIN RELIEVING THERAPY (METHYL SALICYLATE, MENTHOL USP, CAMPHOR) GEL [REED THERAPEUTICS]2
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022YREED THERAPEUTICS PAIN RELIEVING THERAPY (METHYL SALICYLATE, MENTHOL USP, CAMPHOR) GEL [REED THERAPEUTICS]2
CAMPHOR (SYNTHETIC)ACTIVE MOIETY5TJD82A1ETREED THERAPEUTICS PAIN RELIEVING THERAPY (METHYL SALICYLATE, MENTHOL USP, CAMPHOR) GEL [REED THERAPEUTICS]2
CAMPHOR (SYNTHETIC)ACTIVE MOIETY5TJD82A1ETREED THERAPEUTICS PAIN RELIEVING THERAPY (METHYL SALICYLATE, MENTHOL USP, CAMPHOR) GEL [REED THERAPEUTICS]2
MENTHOLACTIVE MOIETYL7T10EIP3AREED THERAPEUTICS PAIN RELIEVING THERAPY (METHYL SALICYLATE, MENTHOL USP, CAMPHOR) GEL [REED THERAPEUTICS]2
MENTHOLACTIVE MOIETYL7T10EIP3AREED THERAPEUTICS PAIN RELIEVING THERAPY (METHYL SALICYLATE, MENTHOL USP, CAMPHOR) GEL [REED THERAPEUTICS]2
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZREED THERAPEUTICS PAIN RELIEVING THERAPY (METHYL SALICYLATE, MENTHOL USP, CAMPHOR) GEL [REED THERAPEUTICS]2
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZREED THERAPEUTICS PAIN RELIEVING THERAPY (METHYL SALICYLATE, MENTHOL USP, CAMPHOR) GEL [REED THERAPEUTICS]2
CARBOMER 940INACTIVE INGREDIENT4Q93RCW27EREED THERAPEUTICS PAIN RELIEVING THERAPY (METHYL SALICYLATE, MENTHOL USP, CAMPHOR) GEL [REED THERAPEUTICS]2
CARBOMER 940INACTIVE INGREDIENT4Q93RCW27EREED THERAPEUTICS PAIN RELIEVING THERAPY (METHYL SALICYLATE, MENTHOL USP, CAMPHOR) GEL [REED THERAPEUTICS]2
DMDM HYDANTOININACTIVE INGREDIENTBYR0546TOWREED THERAPEUTICS PAIN RELIEVING THERAPY (METHYL SALICYLATE, MENTHOL USP, CAMPHOR) GEL [REED THERAPEUTICS]2
DMDM HYDANTOININACTIVE INGREDIENTBYR0546TOWREED THERAPEUTICS PAIN RELIEVING THERAPY (METHYL SALICYLATE, MENTHOL USP, CAMPHOR) GEL [REED THERAPEUTICS]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDREED THERAPEUTICS PAIN RELIEVING THERAPY (METHYL SALICYLATE, MENTHOL USP, CAMPHOR) GEL [REED THERAPEUTICS]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDREED THERAPEUTICS PAIN RELIEVING THERAPY (METHYL SALICYLATE, MENTHOL USP, CAMPHOR) GEL [REED THERAPEUTICS]2
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MREED THERAPEUTICS PAIN RELIEVING THERAPY (METHYL SALICYLATE, MENTHOL USP, CAMPHOR) GEL [REED THERAPEUTICS]2
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MREED THERAPEUTICS PAIN RELIEVING THERAPY (METHYL SALICYLATE, MENTHOL USP, CAMPHOR) GEL [REED THERAPEUTICS]2
ILEX PARAGUARIENSIS WHOLEINACTIVE INGREDIENTQJB02841ZYREED THERAPEUTICS PAIN RELIEVING THERAPY (METHYL SALICYLATE, MENTHOL USP, CAMPHOR) GEL [REED THERAPEUTICS]2
ILEX PARAGUARIENSIS WHOLEINACTIVE INGREDIENTQJB02841ZYREED THERAPEUTICS PAIN RELIEVING THERAPY (METHYL SALICYLATE, MENTHOL USP, CAMPHOR) GEL [REED THERAPEUTICS]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TREED THERAPEUTICS PAIN RELIEVING THERAPY (METHYL SALICYLATE, MENTHOL USP, CAMPHOR) GEL [REED THERAPEUTICS]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TREED THERAPEUTICS PAIN RELIEVING THERAPY (METHYL SALICYLATE, MENTHOL USP, CAMPHOR) GEL [REED THERAPEUTICS]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHREED THERAPEUTICS PAIN RELIEVING THERAPY (METHYL SALICYLATE, MENTHOL USP, CAMPHOR) GEL [REED THERAPEUTICS]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHREED THERAPEUTICS PAIN RELIEVING THERAPY (METHYL SALICYLATE, MENTHOL USP, CAMPHOR) GEL [REED THERAPEUTICS]2
TEA TREE OILINACTIVE INGREDIENTVIF565UC2GREED THERAPEUTICS PAIN RELIEVING THERAPY (METHYL SALICYLATE, MENTHOL USP, CAMPHOR) GEL [REED THERAPEUTICS]2
TEA TREE OILINACTIVE INGREDIENTVIF565UC2GREED THERAPEUTICS PAIN RELIEVING THERAPY (METHYL SALICYLATE, MENTHOL USP, CAMPHOR) GEL [REED THERAPEUTICS]2
THYME OILINACTIVE INGREDIENT2UK410MY6BREED THERAPEUTICS PAIN RELIEVING THERAPY (METHYL SALICYLATE, MENTHOL USP, CAMPHOR) GEL [REED THERAPEUTICS]2
THYME OILINACTIVE INGREDIENT2UK410MY6BREED THERAPEUTICS PAIN RELIEVING THERAPY (METHYL SALICYLATE, MENTHOL USP, CAMPHOR) GEL [REED THERAPEUTICS]2
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKREED THERAPEUTICS PAIN RELIEVING THERAPY (METHYL SALICYLATE, MENTHOL USP, CAMPHOR) GEL [REED THERAPEUTICS]2
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKREED THERAPEUTICS PAIN RELIEVING THERAPY (METHYL SALICYLATE, MENTHOL USP, CAMPHOR) GEL [REED THERAPEUTICS]2
WATERINACTIVE INGREDIENT059QF0KO0RREED THERAPEUTICS PAIN RELIEVING THERAPY (METHYL SALICYLATE, MENTHOL USP, CAMPHOR) GEL [REED THERAPEUTICS]2
WATERINACTIVE INGREDIENT059QF0KO0RREED THERAPEUTICS PAIN RELIEVING THERAPY (METHYL SALICYLATE, MENTHOL USP, CAMPHOR) GEL [REED THERAPEUTICS]2
CAMPHOR (SYNTHETIC)ACTIVE INGREDIENT5TJD82A1ETREED THERAPEUTICS PAIN RELIEVING THERAPY (METHYL SALICYLATE, MENTHOL USP, CAMPHOR) GEL [REED THERAPEUTICS]1
MENTHOLACTIVE INGREDIENTL7T10EIP3AREED THERAPEUTICS PAIN RELIEVING THERAPY (METHYL SALICYLATE, MENTHOL USP, CAMPHOR) GEL [REED THERAPEUTICS]1
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022YREED THERAPEUTICS PAIN RELIEVING THERAPY (METHYL SALICYLATE, MENTHOL USP, CAMPHOR) GEL [REED THERAPEUTICS]1
CAMPHOR (SYNTHETIC)ACTIVE MOIETY5TJD82A1ETREED THERAPEUTICS PAIN RELIEVING THERAPY (METHYL SALICYLATE, MENTHOL USP, CAMPHOR) GEL [REED THERAPEUTICS]1
MENTHOLACTIVE MOIETYL7T10EIP3AREED THERAPEUTICS PAIN RELIEVING THERAPY (METHYL SALICYLATE, MENTHOL USP, CAMPHOR) GEL [REED THERAPEUTICS]1
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZREED THERAPEUTICS PAIN RELIEVING THERAPY (METHYL SALICYLATE, MENTHOL USP, CAMPHOR) GEL [REED THERAPEUTICS]1
CARBOMER 940INACTIVE INGREDIENT4Q93RCW27EREED THERAPEUTICS PAIN RELIEVING THERAPY (METHYL SALICYLATE, MENTHOL USP, CAMPHOR) GEL [REED THERAPEUTICS]1
DMDM HYDANTOININACTIVE INGREDIENTBYR0546TOWREED THERAPEUTICS PAIN RELIEVING THERAPY (METHYL SALICYLATE, MENTHOL USP, CAMPHOR) GEL [REED THERAPEUTICS]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDREED THERAPEUTICS PAIN RELIEVING THERAPY (METHYL SALICYLATE, MENTHOL USP, CAMPHOR) GEL [REED THERAPEUTICS]1
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MREED THERAPEUTICS PAIN RELIEVING THERAPY (METHYL SALICYLATE, MENTHOL USP, CAMPHOR) GEL [REED THERAPEUTICS]1
ILEX PARAGUARIENSIS WHOLEINACTIVE INGREDIENTQJB02841ZYREED THERAPEUTICS PAIN RELIEVING THERAPY (METHYL SALICYLATE, MENTHOL USP, CAMPHOR) GEL [REED THERAPEUTICS]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TREED THERAPEUTICS PAIN RELIEVING THERAPY (METHYL SALICYLATE, MENTHOL USP, CAMPHOR) GEL [REED THERAPEUTICS]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHREED THERAPEUTICS PAIN RELIEVING THERAPY (METHYL SALICYLATE, MENTHOL USP, CAMPHOR) GEL [REED THERAPEUTICS]1
TEA TREE OILINACTIVE INGREDIENTVIF565UC2GREED THERAPEUTICS PAIN RELIEVING THERAPY (METHYL SALICYLATE, MENTHOL USP, CAMPHOR) GEL [REED THERAPEUTICS]1
THYME OILINACTIVE INGREDIENT2UK410MY6BREED THERAPEUTICS PAIN RELIEVING THERAPY (METHYL SALICYLATE, MENTHOL USP, CAMPHOR) GEL [REED THERAPEUTICS]1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKREED THERAPEUTICS PAIN RELIEVING THERAPY (METHYL SALICYLATE, MENTHOL USP, CAMPHOR) GEL [REED THERAPEUTICS]1
WATERINACTIVE INGREDIENT059QF0KO0RREED THERAPEUTICS PAIN RELIEVING THERAPY (METHYL SALICYLATE, MENTHOL USP, CAMPHOR) GEL [REED THERAPEUTICS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76437-609REED THERAPEUTICS PAIN RELIEVING THERAPY (METHYL SALICYLATE, MENTHOL USP, CAMPHOR) GEL [REED THERAPEUTICS]2Legacy NDC, 1 package rows20130130_d4525418-ca10-4fbf-af5f-621a10a41bf8.zip
76437-609REED THERAPEUTICS PAIN RELIEVING THERAPY (METHYL SALICYLATE, MENTHOL USP, CAMPHOR) GEL [REED THERAPEUTICS]2Legacy NDC, 1 package rows20130325_99dcdb92-58f3-4f10-8f4d-d7a1b927e6ce.zip
76437-609REED THERAPEUTICS PAIN RELIEVING THERAPY (METHYL SALICYLATE, MENTHOL USP, CAMPHOR) GEL [REED THERAPEUTICS]1Legacy NDC, 1 package rows20130401_5ee37805-f1c6-467a-bdf2-f67368347e11.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1546102camphor 0.2 % / menthol 4 % / methyl salicylate 12.5 % Topical GelPSN99dcdb92-58f3-4f10-8f4d-d7a1b927e6ce2
1546102camphor 0.2 % / menthol 4 % / methyl salicylate 12.5 % Topical GelPSNd4525418-ca10-4fbf-af5f-621a10a41bf82
1546102camphor 0.002 MG/MG / menthol 0.04 MG/MG / methyl salicylate 0.125 MG/MG Topical GelSCD99dcdb92-58f3-4f10-8f4d-d7a1b927e6ce2
1546102camphor 0.002 MG/MG / menthol 0.04 MG/MG / methyl salicylate 0.125 MG/MG Topical GelSCDd4525418-ca10-4fbf-af5f-621a10a41bf82
1546102camphor 0.2 % / menthol 4 % / methyl salicylate 12.5 % Topical GelSY99dcdb92-58f3-4f10-8f4d-d7a1b927e6ce2
1546102camphor 0.2 % / menthol 4 % / methyl salicylate 12.5 % Topical GelSYd4525418-ca10-4fbf-af5f-621a10a41bf82
1546102camphor 0.2 % / menthol 4 % / methyl salicylate 12.5 % Topical GelPSN5ee37805-f1c6-467a-bdf2-f67368347e111
1546102camphor 0.002 MG/MG / menthol 0.04 MG/MG / methyl salicylate 0.125 MG/MG Topical GelSCD5ee37805-f1c6-467a-bdf2-f67368347e111
1546102camphor 0.2 % / menthol 4 % / methyl salicylate 12.5 % Topical GelSY5ee37805-f1c6-467a-bdf2-f67368347e111

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
76437-609-037643706090387 g in 1 CANISTER87 gHistorical
76437-609-0576437060905150 g in 1 TUBE150 gHistorical
76437-609-1676437060916454 g in 1 BOTTLE, PUMP454 gHistorical