SANO TI AMO RELIEF AND REPAIR PAIN RELIEF
- Product NDC
- 80216-111
- 11-digit product format
- 802160111
- Labeler code
- 80216
- Product ID
- 80216-111_9227e43b-a73e-4401-a9f5-feac2e190e87
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- MENTHOL, UNSPECIFIED FORM, CAMPHOR (SYNTHETIC)
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Sano Ti Amo, LLC
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2019-10-08
- Substance
- CAMPHOR (SYNTHETIC); MENTHOL, UNSPECIFIED FORM
- Active strength
- 3; 13.4 mg/mL; mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
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.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 80216-111 | I | Inactivated by FDA | 2026-08-10 | ||
| excluded package | package | 80216-111 | 80216-111-02 | I | Inactivated by FDA | 2026-08-10 |
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 | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 80216-111-02 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 80216-111-02 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 80216-111-02 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 80216-111-02 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 80216-111-02 | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 80216-111-02 | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 80216-111-02 | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 59361619-24d9-b610-eca6-5a7f25ed5e03 | Product name | 5 | 20240909 |
| 5e18e798-5614-cf5c-0185-38b1cb77a093 | Product name | 2 | 20160822 |
FDA-Initiated Inactive NDC Indexing#
| Effective | Related label |
|---|---|
| 2025-03-21 | DRUG FACTS |
| 2025-01-30 | DRUG FACTS |
| 2022-02-16 | DRUG FACTS |
| 2022-01-28 | DRUG FACTS |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 80216-111-02 | SANO TI AMO RELIEF AND REPAIR PAIN RELIEF | 60 mL in 1 CONTAINER | CREAM | 60 | 4 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 80216-111 | SANO TI AMO RELIEF AND REPAIR PAIN RELIEF (MENTHOL, UNSPECIFIED FORM, CAMPHOR (SYNTHETIC)) CREAM [SANO TI AMO, LLC] | 4 | Current NDC, Legacy NDC, 1 package rows | 20250323_205a89c4-2ae4-4072-af5c-a9ce6154a3f9.zip |
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 |
|---|---|---|---|---|---|---|
| Itch Relief | DIPHENHYDRAMINE HCL, ZINC ACETATE | Cardinal Health, 110 dba Leader | 3ed7b8a1-012f-459d-878c-813b93d4673c | 2026-08-06 | Warnings, Adverse reactions | M017 |
| Gel Cooling Pain Relief | MENTHOL | The Kroger Co. | 6fb0acc8-8dab-452c-b09e-de97306e1c32 | 2026-08-06 | Warnings, Adverse reactions | M017 |
| Lidocaine Tattoo Wipe | LIDOCAINE HYDROCHLORIDE | MD Tattoo Company | 369c1d16-597c-e1dc-e063-6394a90a3104 | 2026-08-06 | Warnings | M017 |
| Point Relief Coldspot Pain Relieving | MENTHOL | Fabrication Enterprises Inc | 479fb728-4aeb-42e3-b238-f04255514baa | 2026-08-05 | Warnings | M017 |
| Lidocaine HCl | LIDOCAINE HCL | Topco Associates LLC | 584e1f35-4d99-9c85-e063-6294a90ab3d0 | 2026-08-05 | Warnings, Adverse reactions | M017 |
| tuiwaro LIDOCAINE Cream | LIDOCAINE CREAM | Guangzhou Jingliang Cosmetics Co., Ltd. | 56e36592-a935-61d4-e063-6294a90a6e4c | 2026-08-04 | Warnings | M017 |
| Mineral Ice Extreme Menthol Pain Relief | MENTHOL | Carlin Consumer Health LLC | 584f5c6e-3385-3221-e063-6294a90aabae | 2026-08-04 | Warnings | M017 |
| hydrocortisone | HYDROCORTISONE | Bryant Ranch Prepack | 484fe5e4-a058-49c0-a382-c8fc3e20c3b2 | 2026-08-04 | Warnings | M017 |
| procure | HYDROCORTISONE ACETATE | TWIN MED, LLC | 2670c9c4-66ad-40e8-a08a-582b160de39d | 2026-08-03 | Warnings | M017 |
| Icy Hot Original Nighttime Recovery Pain Relief No Mess Roll On | MENTHOL | Chattem, Inc. | aa40c907-eeb5-4fda-b35e-439cbecc178c | 2026-07-31 | Warnings | M017 |
| Alphamale Delay Cream | BENZOCAINE | Prodigy Media Inc | 53d682ee-0802-a16d-e063-6394a90aeee1 | 2026-07-31 | Warnings | M017 |
| Pure Primal Delay Cream | BENZOCAINE | Prodigy Media Inc | 57e9e894-c14f-d806-e063-6394a90ab8e5 | 2026-07-31 | Warnings | M017 |
| Satohap | DL-CAMPHOR, L-MENTHOL, METHYL SALICYLATE | Sato Pharmaceutical Co., Ltd. | df0e2b83-8f61-4ed8-bcc4-55e4ea782090 | 2026-07-31 | Warnings | M017 |
| Satogesic | DL-CAMPHOR, L-MENTHOL, METHYL SALICYLATE | Sato Pharmaceutical Co., Ltd. | cb000134-92a4-4304-8ef0-0347190e1414 | 2026-07-31 | Warnings | M017 |
| Satogesic Hot | CAPSAICIN | Sato Pharmaceutical Co., Ltd. | 16b47cb5-ea5f-4514-9a89-141ee4cc60f8 | 2026-07-31 | Warnings | M017 |
| Satohap Cool and Hot Pads | CAMPHOR, CAPSAICIN, MENTHOL | Sato Pharmaceutical Co., Ltd. | b6bf1eab-4ab9-f500-e053-2995a90a8d7b | 2026-07-31 | Warnings, Adverse reactions | M017 |
| SATOHAP COOL and HOT | CAMPHOR, CAPSAICIN, MENTHOL | Sato Pharmaceuticals Co., Ltd. | 232a4c76-1a0c-2f4b-e063-6394a90a8849 | 2026-07-31 | Warnings, Adverse reactions | M017 |
| Cortizone 10 Itch Relief Massaging Rollerball | HYDROCORTISONE | Chattem, Inc. | 1e27682c-f856-41f1-9935-37540960a4c7 | 2026-07-31 | Warnings | M017 |
| Aspercreme with Lidocaine Dry | LIDOCAINE | Chattem, Inc. | 008abaaa-5e12-4246-a7f5-66f3966acf28 | 2026-07-30 | Warnings | M017 |
| ACOLYE Lidocaine Cream Topical Analgesia Cream | LIDOCAINE,MENTHOL | Guangdong Aimu Biological Technology Co., Ltd | 57deebf7-52f1-4256-e063-6294a90a75d5 | 2026-07-30 | Warnings | M017 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 80216-111-02 | 80216011102 | 60 mL in 1 CONTAINER (80216-111-02) | 60 ml | 2019-10-08 | 0000-00-00 | No | No | Current |