Menthol and Zinc Oxide
- Product NDC
- 69771-013
- 11-digit product format
- 697710013
- Labeler code
- 69771
- Product ID
- 69771-013_2b0e344b-8e5b-2995-e063-6394a90a9cbc
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Menthol and Zinc Oxide
- Dosage form
- OINTMENT
- Route
- TOPICAL
- Labeler
- GERI-GENTLE CORPORATION
- Application
- M016
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2022-08-17
- Substance
- MENTHOL; ZINC OXIDE
- Active strength
- .44; 20.625 g/100g; 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 |
|---|---|---|---|---|---|
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 69771-013-23 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 69771-013-23 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 69771-013-23 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded product | product | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 69771-013-23 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded product | product | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 69771-013-23 | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 69771-013-23 | 1332a3947898… | d4bfe170f9cd… |
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
- Menthol and Zinc Oxide
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| MENTHOL | .44 g/100g |
| ZINC OXIDE | 20.625 g/100g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| L7T10EIP3A | Internal UNII lookup |
| SOI2LOH54Z | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 2123045 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| e673d8bd-2573-9f04-e053-2995a90a172a | Available on FDA.report |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 69771-013-23 | 2025-01-06 | C162847 | 48780-1 | 1030e365-237a-111a-e063-dadaa90a10e2 | GG Tender Calm Menthol 0.44% w/w…………….……External Analgesic Zinc Oxide 20.625% w/w………………. Skin Protectant |
| 69771-013-23 | 2024-01-30 | C162847 | 48780-1 | 1030e365-237a-111a-e063-dadaa90a10e2 | GG Tender Calm Menthol 0.44% w/w…………….……External Analgesic Zinc Oxide 20.625% w/w………………. Skin Protectant |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69771-013-23 | Menthol and Zinc Oxide | 113 g in 1 TUBE | OINTMENT | 113 | 3 |
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 |
|---|---|---|---|---|---|---|
| EIGHT HOUR SKIN FRAGRANCE FREE | PETROLATUM | REVLON | b61d6e2e-18dd-37d2-e053-2a95a90af57b | 2025-08-01 | Warnings | M016 |
| Vigority Wild Yam Cream | ESTRIOL CREAM | FOUNDATION COMMERCE INC | 39b2bef7-46c5-9ad5-e063-6294a90ae983 | 2025-07-30 | Warnings | M016 |
| Rugby Caldyphen Clear | PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE LOTION | Rugby Laboratories | 9af3a740-ef97-26ce-e053-2a95a90a0ee1 | 2025-07-28 | Warnings | M016 |
| Aveeno Baby Eczema Therapy Soothing Bath Treatment | OATMEAL | Kenvue Brands LLC | e7eb10b7-3950-49cb-ba73-11e7581b6be9 | 2025-07-25 | Warnings | M016 |
| ProCure SkinGuard | PETROLATUM 49.9% | Twin Med LLC | 3a1721f6-1bb0-cd47-e063-6394a90a148e | 2025-07-25 | Warnings | M016 |
| ProCure HydroCerin | PETROLATUM 33% | Twin Med LLC | 3ab7248d-b914-9fdd-e063-6294a90ac4c8 | 2025-07-24 | Warnings | M016 |
| AD PREVENT Original | AD PREVENT ORIGINAL | WellSpring Pharmaceutical Corporation | cf73246e-81c1-42e9-a107-dc6c99cf7d01 | 2025-07-24 | Warnings | M016 |
| Dimethicone 1 Skin Protectant | DIMETHICONE | Universal Distribution Center LLC | 2c5b96b9-24d6-4223-a63d-fe83d7c02368 | 2025-07-24 | Warnings | M016 |
| Dr Butlers Soothing Incontinence | MINERAL OIL 59.8%, PETROLATUM 36.0% | Beyond Health PA | 3a9d3796-fd05-fe57-e063-6294a90a0ac6 | 2025-07-23 | Warnings | M016 |
| A and D plus E | VITAMIN A, D AND E OINTMENT | Derma Sciences Canada Inc. | 35aca592-bfd0-652f-e063-6394a90ac53e | 2025-07-22 | Warnings | M016 |
| Petroleum Jelly | PETROLATUM | Derma Sciences Canada Inc. | 3a895e6c-da8d-db9b-e063-6394a90ace40 | 2025-07-22 | Warnings | M016 |
| Petroleum Jelly | PETROLEUM JELLY | NeilMed Pharmaceuticals Inc. | 36bbbb1e-78e9-98f6-e063-6294a90a66d1 | 2025-07-21 | Warnings | M016 |
| Mountain Ice Eczema | COLLOIDAL OATMEAL | Mountainside Medical Equipment, Inc. | 1a91f33e-dd85-4d5a-b61c-e460a507e292 | 2025-07-21 | Warnings | M016 |
| Our Eczema Remedy | COLLOIDAL OATMEAL | Fewer Better Things | 3a755b4c-47c8-9ca5-e063-6394a90af84a | 2025-07-21 | Warnings | M016 |
| Aveeno DAILY MOISTURIZING | DIMETHICONE | Kenvue Brands LLC | 54a13b85-32b5-439d-a27a-8fba2cf44251 | 2025-07-16 | Warnings | M016 |
| ProCure Moisture Barrier | 1% DIMETHICONE, 12% ZINC OXIDE | Twin Med LLC | 3988c83b-d4eb-1f09-e063-6394a90a45ad | 2025-07-14 | Warnings | M016 |
| Avalon Organics Antidandruff Conditioner | SALICYLIC ACID | The Hain Celestial Group, Inc. | 66db1071-022a-aa19-e053-2a91aa0a8e39 | 2025-07-11 | Warnings | M016 |
| Avalon Organics Antidandruff | SALICYLIC ACID | The Hain Celestial Group, Inc. | 66c7f730-64f3-4eef-e053-2a91aa0a4225 | 2025-07-11 | Warnings | M016 |
| terrasil Infection Protection Wound Care Maximum Strength | ALLANTOIN | Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions | 9e7843e2-ca69-40f5-a4ce-da6b03ebe7f7 | 2025-07-11 | Warnings | M016 |
| terrasil Skin Repair | ALLANTOIN | Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions | 92a23c7f-6b89-49cb-93e2-49ab7a85c86d | 2025-07-11 | Warnings | M016 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2123045 | menthol 0.44 % / zinc oxide 20.6 % Topical Ointment | PSN | e673d8bd-2573-9f04-e053-2995a90a172a | 3 |
| 2123045 | menthol 0.0044 MG/MG / zinc oxide 0.206 MG/MG Topical Ointment | SCD | e673d8bd-2573-9f04-e053-2995a90a172a | 3 |
| 2123045 | Menthol 0.0044 MG/MG / ZNO 0.206 MG/MG Topical Ointment | SY | e673d8bd-2573-9f04-e053-2995a90a172a | 3 |
| 2123045 | menthol 0.44 % / zinc oxide 20.6 % Topical Ointment | SY | e673d8bd-2573-9f04-e053-2995a90a172a | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 69771-013-23 | 69771001323 | 113 g in 1 TUBE (69771-013-23) | 113 g | 2022-08-17 | 0000-00-00 | No | No | Current |