FDA.reportPublic FDA data

BioTemper

Product NDC
71718-111
Requested package NDC
71718-111-05
11-digit product format
717180111
Labeler code
71718
Product ID
71718-111_0129a051-8516-432c-85af-65bb5a3f1092
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
LIQUID
Route
TOPICAL
Labeler
Scientific Solutions Global Llc
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2017-08-03
Marketing end
0000-00-00
Substance
MENTHOL, UNSPECIFIED FORM
Active strength
10 g/100mL
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage71718-11171718-111-05IInactivated by FDA2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 19 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-278dfbde2a14a4…c9ff85d89658…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
111d457e-3138-4512-b0ba-d0cd760c4055Product name320250225
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
0426261e-1bb9-b78b-abd2-80da765a7e3eProduct name220240513
7b6158ae-c3f4-3d73-c35f-6f5d18b9efd7Product name520240320
0ac2f11f-f58d-baf2-71a0-680993b48a61Product name220231211
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
855d63c3-b090-4636-8fc7-6d39ad23c44fProduct name120230829
bb58f410-04be-65dd-9211-e89ead899698Product name620230323
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
0fcbc38a-8b29-3348-1cef-5222ea53484fProduct name420220516
c4e1eedc-aca2-4551-8382-89144ed9d049Product name320220126
8d368a34-1453-43ea-828d-0dbcd72b8794Product name820210622
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
d6bab9d2-edce-a213-4796-226ab15472c3Product name620200616
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
2487e6ef-d419-42fc-aaf8-7acc805d2370Product name220170718
e071c814-e5e7-e7ed-ec76-428765d9c66bProduct name220151120
93148e06-b8d7-4e6c-853e-62f807d17fbbProduct name120151014
dbb00be6-fb1c-4b0a-a770-31f7e05e247eProduct name120150316
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
71718-111-012021-07-23BIOTEMPER
71718-111-022021-07-23BIOTEMPER
71718-111-032021-07-23BIOTEMPER
71718-111-042021-07-23BIOTEMPER
71718-111-052021-07-23BIOTEMPER
71718-111-062021-07-23BIOTEMPER
71718-111-012020-02-16BIOTEMPER
71718-111-022020-02-16BIOTEMPER
71718-111-032020-02-16BIOTEMPER
71718-111-042020-02-16BIOTEMPER
71718-111-052020-02-16BIOTEMPER
71718-111-062020-02-16BIOTEMPER
71718-111-012020-01-31BIOTEMPER
71718-111-022020-01-31BIOTEMPER
71718-111-032020-01-31BIOTEMPER
71718-111-042020-01-31BIOTEMPER
71718-111-052020-01-31BIOTEMPER
71718-111-062020-01-31BIOTEMPER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71718-111-01BioTemper89 mL in 1 BOTTLELIQUID893
71718-111-02BioTemper2 in 1 PACKAGELIQUID23
71718-111-02BioTemper89 mL in 1 BOTTLELIQUID893
71718-111-03BioTemper89 mL in 1 BOTTLELIQUID893
71718-111-03BioTemper3 in 1 PACKAGELIQUID33
71718-111-04BioTemper89 mL in 1 BOTTLELIQUID893
71718-111-04BioTemper4 in 1 PACKAGELIQUID43
71718-111-05BioTemper6 in 1 PACKAGELIQUID63
71718-111-05BioTemper89 mL in 1 BOTTLELIQUID893
71718-111-06BioTemper89 mL in 1 BOTTLELIQUID893
71718-111-06BioTemper12 in 1 PACKAGELIQUID123

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71718-111BIOTEMPER (MENTHOL) LIQUID [SCIENTIFIC SOLUTIONS GLOBAL LLC]3Legacy NDC, 11 package rows20200217_1486c893-ec00-4603-93fd-01f68b7e0b81.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1600976menthol 10 % Topical SolutionPSN1486c893-ec00-4603-93fd-01f68b7e0b813
1600976menthol 100 MG/ML Topical SolutionSCD1486c893-ec00-4603-93fd-01f68b7e0b813
1600976menthol 10 % Topical SolutionSY1486c893-ec00-4603-93fd-01f68b7e0b813
857700diclofenac sodium 1.5 % Topical SolutionPSNe786e7bf-a143-428d-b3e2-bc82eca2f2661
857700diclofenac sodium 1.5 % Topical SolutionPSN82a170b6-fd2c-48ad-97dc-bd4e9c85f53e1
1543069lidocaine 5 % Topical OintmentPSN2d97e75c-7dfd-417e-b8f3-31e8b5dd90fe1
1600976menthol 10 % Topical SolutionPSNe786e7bf-a143-428d-b3e2-bc82eca2f2661
1600976menthol 10 % Topical SolutionPSN2d97e75c-7dfd-417e-b8f3-31e8b5dd90fe1
1600976menthol 10 % Topical SolutionPSN82a170b6-fd2c-48ad-97dc-bd4e9c85f53e1
857700diclofenac sodium 15 MG/ML Topical SolutionSCDe786e7bf-a143-428d-b3e2-bc82eca2f2661
857700diclofenac sodium 15 MG/ML Topical SolutionSCD82a170b6-fd2c-48ad-97dc-bd4e9c85f53e1
1543069lidocaine 0.05 MG/MG Topical OintmentSCD2d97e75c-7dfd-417e-b8f3-31e8b5dd90fe1
1600976menthol 100 MG/ML Topical SolutionSCD82a170b6-fd2c-48ad-97dc-bd4e9c85f53e1
1600976menthol 100 MG/ML Topical SolutionSCD2d97e75c-7dfd-417e-b8f3-31e8b5dd90fe1
1600976menthol 100 MG/ML Topical SolutionSCDe786e7bf-a143-428d-b3e2-bc82eca2f2661
857700diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical SolutionSY82a170b6-fd2c-48ad-97dc-bd4e9c85f53e1
857700diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical SolutionSYe786e7bf-a143-428d-b3e2-bc82eca2f2661
857700diclofenac sodium 16.05 MG per 1 ML Topical SolutionSY82a170b6-fd2c-48ad-97dc-bd4e9c85f53e1
857700diclofenac sodium 16.05 MG per 1 ML Topical SolutionSYe786e7bf-a143-428d-b3e2-bc82eca2f2661
1543069lidocaine 5 % Topical OintmentSY2d97e75c-7dfd-417e-b8f3-31e8b5dd90fe1
1600976menthol 10 % Topical SolutionSY82a170b6-fd2c-48ad-97dc-bd4e9c85f53e1
1600976menthol 10 % Topical SolutionSYe786e7bf-a143-428d-b3e2-bc82eca2f2661
1600976menthol 10 % Topical SolutionSY2d97e75c-7dfd-417e-b8f3-31e8b5dd90fe1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71718-111-05717180111056 BOTTLE in 1 PACKAGE (71718-111-05) > 89 mL in 1 BOTTLE6 bottle2017-08-030000-00-00NoNoCurrent