PR
- Product NDC
- 72358-101
- 11-digit product format
- 723580101
- Labeler code
- 72358
- Product ID
- 72358-101_4229f4ae-8934-0e10-e063-6394a90a4185
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Menthol
- Dosage form
- LOTION
- Route
- TOPICAL
- Labeler
- Amphp, Inc
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2018-11-01
- Substance
- MENTHOL
- Active strength
- .5 g/100g
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
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.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 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 | 72358-101-04 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 72358-101-03 | 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 | 72358-101-04 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 72358-101-03 | 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 | 72358-101-04 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 72358-101-03 | 0efc9e666f02… | f202fb6c5f17… |
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
- PR
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| MENTHOL | .5 g/100g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| L7T10EIP3A | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1293193 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 6f5b9e08-c445-4fac-e053-2a91aa0aa737 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| fb7ab793-2c12-4079-b100-a64f73bef25a | Product name | 4 | 20240712 |
| b0cbf770-6cc3-4aa4-9158-755110c2b9f7 | Product name | 2 | 20230717 |
| dc7c5daa-021f-40dd-b00d-63982cb2067a | Product name | 1 | 20230426 |
| 08ffbcbf-26df-b99c-1dab-64fc4cfae89f | Product name | 5 | 20200925 |
| 816b97af-edc5-4060-aff1-b814bdbcad50 | Product name | 1 | 20190415 |
| 7cda52fc-125f-421c-8fea-bc1974370c49 | Product name | 2 | 20180703 |
| 419aab54-5d5a-4146-9453-026d4a9991be | Product name | 2 | 20170525 |
| 08ffbcbf-26df-b99c-1dab-64fc4cfae89f | Product name | 2 | 20160823 |
| 89dac932-b90a-4410-9ab1-84c53e57de25 | Product name | 1 | 20150316 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 72358-101-03 | PR | 20 g in 1 PACKET | LOTION | 20 | 9 | |
| 72358-101-04 | PR | 300 g in 1 BOTTLE, PLASTIC | LOTION | 300 | 9 |
DailyMed Dashboard NDC Coverage#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Hemorrhoidal Pain Relief Cream | GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM | WALGREENS | 03bbe146-f185-bcfa-e063-6394a90a85bf | 2023-12-04 | Warnings | M017 |
| Quatriderm Anti-itch | HYDROCORTISONE | OPMX LLC | 83e59e10-9878-e5c2-e053-2a91aa0af25e | 2023-12-04 | Warnings | M017 |
| TACT | DIPHENHYDRAMINE HYDROCHLORIDE, MENTHOL | Sato Pharmaceutical Inc., Ltd. | b6e2ee24-69de-4dfd-9081-b9537b7a7bad | 2023-12-04 | Warnings | M017 |
| Overnight Cold Therapy Pain Relief | MENTHOL, UNSPECIFIED FORM | Walgreen Co. | 2cbd0966-4cf9-4271-bd53-6672b1ed2a99 | 2023-12-04 | Warnings | M017 |
| Prolayed Lidocaine Male Genital Desensitizer | LIDOCAINE | ViaDerma Distribution, Inc. | 9c5ad0d0-ca7a-4321-9334-f06f3f6be18f | 2023-12-02 | Warnings | M017 |
| Liberdol Topical Analgesic | METHYL SALICYLATE, MENTHOL, CAMPHOR (SYNTHETIC) | ViaDerma Distribution, Inc | ab52cd0e-34fa-41c7-9ce7-1183c2aff8d8 | 2023-12-01 | Warnings | M017 |
| Prolayed | LIDOCAINE | MATRIX MIXOLOGY, INC | ae317876-adb1-6d13-e053-2995a90a74af | 2023-12-01 | Warnings | M017 |
| Tact Cool Jelly | DIPHENHYDRAMINE HYDROCHLORIDE, LEVOMENTHOL | Sato Pharmaceutical Co., Ltd. | f34872c9-91b9-49db-8e41-5b54a069284a | 2023-12-01 | Warnings | M017 |
| Satohap | METHYL SALICYLATE, DL-CAMPHOR, L-MENTHOL | Sato Pharmaceutical Co., Ltd. | 348fde05-2797-4410-a1b2-99e64187c4fe | 2023-12-01 | Warnings | M017 |
| Menthozen Hydrogel | MENTHOL, CAPSAICIN | Proficient Rx LP | 85a7809e-c43f-4138-a85b-44e1b586def5 | 2023-12-01 | Warnings | M017 |
| Menthozen Cream | METHYL SALICYLATE, MENTHOL, CAPSAICIN | Proficient Rx LP | 66681906-c5f5-4c57-bb43-9c83cccc0062 | 2023-12-01 | Warnings | M017 |
| Lidozen Patch | LIDOCAINE, MENTHOL | Proficient Rx LP | c0df4b8b-2679-4652-9144-a8db916a186b | 2023-12-01 | Warnings | M017 |
| Lidozen Gel | LIDOCAINE HYDROCHLORIDE, MENTHOL | Proficient Rx LP | 7c300dec-cefd-4b79-a948-a917b7708a04 | 2023-12-01 | Warnings | M017 |
| Menthozen | METHYL SALICYLATE, MENTHOL, CAPSAICIN | Proficient Rx LP | 2adf3c4d-636f-4e02-b501-946b4df5f5d6 | 2023-12-01 | Warnings | M017 |
| Lidozen | LIDOCAINE, MENTHOL | Proficient Rx LP | 488d665c-a4fe-4a69-bab3-34b2347f4b05 | 2023-12-01 | Warnings | M017 |
| Thera Plus Max Strength Lidocaine Pain Relief Liquid | LIDOCAINE HYDROCHLORIDE | Fourstar Group USA, Inc. | 0a228b06-0e1c-6c75-e063-6294a90a9a0e | 2023-11-30 | Warnings | M017 |
| Thera Plus Cool and Heat Pain Relieving Gel Menthol | MENTHOL | Fourstar Group USA, Inc. | 0a225714-ccb1-4676-e063-6294a90aeeb2 | 2023-11-30 | Warnings | M017 |
| Bloop Itch Soothing Topical | HYDROCORTISONE | Three Nations Corp | 0b64677e-d4bf-0929-e063-6294a90af137 | 2023-11-30 | Warnings | M017 |
| Ice Quake | MENTHOL | Southern Sales & Service, Inc. | 7a05832f-49ac-4013-b240-4405501e45cd | 2023-11-29 | Warnings | M017 |
| ICE MUSCLE RUB Leon M.C | MENTHOL | Southern Sales & Service, Inc. | 4efaf347-7406-4690-8005-e7cf2e3d4222 | 2023-11-29 | Warnings | M017 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1293193 | menthol 0.5 % Topical Lotion | PSN | 6f5b9e08-c445-4fac-e053-2a91aa0aa737 | 9 |
| 1293193 | menthol 5 MG/ML Topical Lotion | SCD | 6f5b9e08-c445-4fac-e053-2a91aa0aa737 | 9 |
| 1293193 | menthol 0.5 % Topical Lotion | SY | 6f5b9e08-c445-4fac-e053-2a91aa0aa737 | 9 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 72358-101-01 | 72358010101 | 300 g in 1 TUBE (72358-101-01) | 300 g | 2018-11-01 | 0000-00-00 | No | No | Current |
| 72358-101-02 | 72358010102 | 100 g in 1 TUBE (72358-101-02) | 100 g | 2018-11-01 | 0000-00-00 | No | No | Current |
| 72358-101-03 | 72358010103 | 20 g in 1 PACKET (72358-101-03) | 20 g | 2018-11-01 | 0000-00-00 | No | No | Current |
| 72358-101-04 | 72358010104 | 300 g in 1 BOTTLE, PLASTIC (72358-101-04) | 300 g | 2018-11-01 | 0000-00-00 | No | No | Current |