BioTemper

Product NDC: 71718-111
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 · 7 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	71718-111		I	Inactivated by FDA	2026-10-05
excluded package	package	71718-111	71718-111-01	I	Inactivated by FDA	2026-10-05
excluded package	package	71718-111	71718-111-02	I	Inactivated by FDA	2026-10-05
excluded package	package	71718-111	71718-111-03	I	Inactivated by FDA	2026-10-05
excluded package	package	71718-111	71718-111-04	I	Inactivated by FDA	2026-10-05
excluded package	package	71718-111	71718-111-05	I	Inactivated by FDA	2026-10-05
excluded package	package	71718-111	71718-111-06	I	Inactivated by FDA	2026-10-05

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 3 · 133 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71718-111-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71718-111-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71718-111-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71718-111-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71718-111-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71718-111-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71718-111-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71718-111-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71718-111-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71718-111-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71718-111-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71718-111-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71718-111-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71718-111-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71718-111-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71718-111-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71718-111-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71718-111-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71718-111-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71718-111-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71718-111-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71718-111-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71718-111-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71718-111-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71718-111-06	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71718-111-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71718-111-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71718-111-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71718-111-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71718-111-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71718-111-06	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71718-111-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71718-111-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71718-111-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71718-111-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71718-111-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	71718-111-06	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	71718-111-04	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	71718-111-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	71718-111-05	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	71718-111-03	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	71718-111-02	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	71718-111-06	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	71718-111-04	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	71718-111-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	71718-111-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	71718-111-03	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	71718-111-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	71718-111-06	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	71718-111-04	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	71718-111-01	`0efc9e666f02…`	`f202fb6c5f17…`

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 concept	Relation	Version	Effective
070fbed5-7088-434a-a7ce-f2a64d8d40ac	Product name	2	20260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80f	Product name	5	20250819
111d457e-3138-4512-b0ba-d0cd760c4055	Product name	3	20250225
860a93dc-4863-49cc-b284-6bbe8191bc48	Product name	4	20250214
eaba870a-6a9d-442e-8643-87b3f558a451	Product name	1	20250117
0426261e-1bb9-b78b-abd2-80da765a7e3e	Product name	2	20240513
7b6158ae-c3f4-3d73-c35f-6f5d18b9efd7	Product name	5	20240320
0ac2f11f-f58d-baf2-71a0-680993b48a61	Product name	2	20231211
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
855d63c3-b090-4636-8fc7-6d39ad23c44f	Product name	1	20230829
bb58f410-04be-65dd-9211-e89ead899698	Product name	6	20230323
9b4cf230-fd05-41d5-98c6-5db9ecb27b86	Product name	1	20230117
0fcbc38a-8b29-3348-1cef-5222ea53484f	Product name	4	20220516
c4e1eedc-aca2-4551-8382-89144ed9d049	Product name	3	20220126
8d368a34-1453-43ea-828d-0dbcd72b8794	Product name	8	20210622
7d755fa1-1087-4dcd-98f0-6d4bba479a57	Product name	3	20210602
d6bab9d2-edce-a213-4796-226ab15472c3	Product name	6	20200616
aed701d5-9c75-dfaf-7154-cde46179faea	Product name	9	20200313
fa8b5901-e681-426f-82fe-54f6d81ec698	Product name	4	20180619
332d03e4-aa24-4b11-841a-02bf41081920	Product name	1	20171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070	Product name	1	20171221
2487e6ef-d419-42fc-aaf8-7acc805d2370	Product name	2	20170718
e071c814-e5e7-e7ed-ec76-428765d9c66b	Product name	2	20151120
93148e06-b8d7-4e6c-853e-62f807d17fbb	Product name	1	20151014
dbb00be6-fb1c-4b0a-a770-31f7e05e247e	Product name	1	20150316
68ed98f8-24c2-44a0-944a-6d36e82ce25a	Product name	1	20141222
1cd42bc2-a430-c72b-636d-991b235fbf80	Product name	1	20140508
49fa150c-f0de-cce7-3d9c-993ed81c5698	Product name	1	20140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ff	Product name	1	20140508
9137811f-f279-8640-5aeb-99fa2145d64d	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
71718-111-01	2021-07-23	BIOTEMPER
71718-111-02	2021-07-23	BIOTEMPER
71718-111-03	2021-07-23	BIOTEMPER
71718-111-04	2021-07-23	BIOTEMPER
71718-111-05	2021-07-23	BIOTEMPER
71718-111-06	2021-07-23	BIOTEMPER
71718-111-01	2020-02-16	BIOTEMPER
71718-111-02	2020-02-16	BIOTEMPER
71718-111-03	2020-02-16	BIOTEMPER
71718-111-04	2020-02-16	BIOTEMPER
71718-111-05	2020-02-16	BIOTEMPER
71718-111-06	2020-02-16	BIOTEMPER
71718-111-01	2020-01-31	BIOTEMPER
71718-111-02	2020-01-31	BIOTEMPER
71718-111-03	2020-01-31	BIOTEMPER
71718-111-04	2020-01-31	BIOTEMPER
71718-111-05	2020-01-31	BIOTEMPER
71718-111-06	2020-01-31	BIOTEMPER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71718-111-01	BioTemper	89 mL in 1 BOTTLE	LIQUID	89	3
71718-111-02	BioTemper	2 in 1 PACKAGE	LIQUID	2	3
71718-111-02	BioTemper	89 mL in 1 BOTTLE	LIQUID	89	3
71718-111-03	BioTemper	89 mL in 1 BOTTLE	LIQUID	89	3
71718-111-03	BioTemper	3 in 1 PACKAGE	LIQUID	3	3
71718-111-04	BioTemper	89 mL in 1 BOTTLE	LIQUID	89	3
71718-111-04	BioTemper	4 in 1 PACKAGE	LIQUID	4	3
71718-111-05	BioTemper	6 in 1 PACKAGE	LIQUID	6	3
71718-111-05	BioTemper	89 mL in 1 BOTTLE	LIQUID	89	3
71718-111-06	BioTemper	89 mL in 1 BOTTLE	LIQUID	89	3
71718-111-06	BioTemper	12 in 1 PACKAGE	LIQUID	12	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71718-111	BIOTEMPER (MENTHOL) LIQUID [SCIENTIFIC SOLUTIONS GLOBAL LLC]	3	Legacy NDC, 11 package rows	20200217_1486c893-ec00-4603-93fd-01f68b7e0b81.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
L7T10EIP3A	MENTHOL, UNSPECIFIED FORM	1490-04-6	MENTHOL, UNSPECIFIED FORM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1600976	menthol 10 % Topical Solution	PSN	1486c893-ec00-4603-93fd-01f68b7e0b81	3
1600976	menthol 100 MG/ML Topical Solution	SCD	1486c893-ec00-4603-93fd-01f68b7e0b81	3
1600976	menthol 10 % Topical Solution	SY	1486c893-ec00-4603-93fd-01f68b7e0b81	3
857700	diclofenac sodium 1.5 % Topical Solution	PSN	e786e7bf-a143-428d-b3e2-bc82eca2f266	1
857700	diclofenac sodium 1.5 % Topical Solution	PSN	82a170b6-fd2c-48ad-97dc-bd4e9c85f53e	1
1543069	lidocaine 5 % Topical Ointment	PSN	2d97e75c-7dfd-417e-b8f3-31e8b5dd90fe	1
1600976	menthol 10 % Topical Solution	PSN	e786e7bf-a143-428d-b3e2-bc82eca2f266	1
1600976	menthol 10 % Topical Solution	PSN	2d97e75c-7dfd-417e-b8f3-31e8b5dd90fe	1
1600976	menthol 10 % Topical Solution	PSN	82a170b6-fd2c-48ad-97dc-bd4e9c85f53e	1
857700	diclofenac sodium 15 MG/ML Topical Solution	SCD	e786e7bf-a143-428d-b3e2-bc82eca2f266	1
857700	diclofenac sodium 15 MG/ML Topical Solution	SCD	82a170b6-fd2c-48ad-97dc-bd4e9c85f53e	1
1543069	lidocaine 0.05 MG/MG Topical Ointment	SCD	2d97e75c-7dfd-417e-b8f3-31e8b5dd90fe	1
1600976	menthol 100 MG/ML Topical Solution	SCD	82a170b6-fd2c-48ad-97dc-bd4e9c85f53e	1
1600976	menthol 100 MG/ML Topical Solution	SCD	2d97e75c-7dfd-417e-b8f3-31e8b5dd90fe	1
1600976	menthol 100 MG/ML Topical Solution	SCD	e786e7bf-a143-428d-b3e2-bc82eca2f266	1
857700	diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical Solution	SY	82a170b6-fd2c-48ad-97dc-bd4e9c85f53e	1
857700	diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical Solution	SY	e786e7bf-a143-428d-b3e2-bc82eca2f266	1
857700	diclofenac sodium 16.05 MG per 1 ML Topical Solution	SY	82a170b6-fd2c-48ad-97dc-bd4e9c85f53e	1
857700	diclofenac sodium 16.05 MG per 1 ML Topical Solution	SY	e786e7bf-a143-428d-b3e2-bc82eca2f266	1
1543069	lidocaine 5 % Topical Ointment	SY	2d97e75c-7dfd-417e-b8f3-31e8b5dd90fe	1
1600976	menthol 10 % Topical Solution	SY	82a170b6-fd2c-48ad-97dc-bd4e9c85f53e	1
1600976	menthol 10 % Topical Solution	SY	e786e7bf-a143-428d-b3e2-bc82eca2f266	1
1600976	menthol 10 % Topical Solution	SY	2d97e75c-7dfd-417e-b8f3-31e8b5dd90fe	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71718-111-01	71718011101	89 mL in 1 BOTTLE (71718-111-01)	89 ml	2017-08-03	0000-00-00	No	No	Current
71718-111-02	71718011102	2 BOTTLE in 1 PACKAGE (71718-111-02) > 89 mL in 1 BOTTLE	2 bottle	2017-08-03	0000-00-00	No	No	Current
71718-111-03	71718011103	3 BOTTLE in 1 PACKAGE (71718-111-03) > 89 mL in 1 BOTTLE	3 bottle	2017-08-03	0000-00-00	No	No	Current
71718-111-04	71718011104	4 BOTTLE in 1 PACKAGE (71718-111-04) > 89 mL in 1 BOTTLE	4 bottle	2017-08-03	0000-00-00	No	No	Current
71718-111-05	71718011105	6 BOTTLE in 1 PACKAGE (71718-111-05) > 89 mL in 1 BOTTLE	6 bottle	2017-08-03	0000-00-00	No	No	Current
71718-111-06	71718011106	12 BOTTLE in 1 PACKAGE (71718-111-06) > 89 mL in 1 BOTTLE	12 bottle	2017-08-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
BIOTEMPER	Scientific Solutions Global Llc	2020-02-07	HUMAN OTC DRUG LABEL	3
LidoStream	Upstream Pharma, LLC	2019-10-30	HUMAN PRESCRIPTION DRUG LABEL	1
Diclostream	Upstream Pharma, LLC	2019-10-24	HUMAN PRESCRIPTION DRUG LABEL	1
DiMentho - Levins Pharmaceuticals, LLC	Levins Pharmaceuticals, LLC	2019-10-01	HUMAN PRESCRIPTION DRUG LABEL	1