Extra Strength Balm
- Product NDC
- 70983-027
- 11-digit product format
- 709830027
- Labeler code
- 70983
- Product ID
- 70983-027_484f4f3a-5682-ca7d-e063-6394a90a982c
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Capsicum and Menthol
- Dosage form
- OINTMENT
- Route
- TOPICAL
- Labeler
- Saje Natural Business Inc
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-02-18
- Substance
- MENTHOL; CAPSICUM
- Active strength
- 2258.75; 5000 mg/g; mg/g
- Pharmacologic classes
- Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Vegetable Proteins [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
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
- Extra Strength Balm
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| MENTHOL | 2258.75 mg/g |
| CAPSICUM | 5000 mg/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| L7T10EIP3A | Internal UNII lookup |
| 00UK7646FG | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| f516e416-446b-8f21-e053-2a95a90afd88 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| baf7f49c-75b6-496b-a00e-8e766a8e4f03 | Product name | 1 | 20210127 |
| ebc62596-fc97-4d03-9483-7ba095d25db7 | Product name | 1 | 20151210 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70983-027-01 | Extra Strength Balm | 1 in 1 BOX | OINTMENT | 1 | 4 | |
| 70983-027-01 | Extra Strength Balm | 25 g in 1 JAR | OINTMENT | 25 | 4 |
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 |
|---|---|---|---|---|---|---|
| Non-proprietary name | HEADACHE PATCH | Nanjing 3H Medical Products Co.,Ltd. | 586d73f1-0b0b-f596-e063-6394a90a4d57 | 2026-08-06 | Warnings | M017 |
| Point Relief Coldspot Pain Relieving | MENTHOL | Fabrication Enterprises Inc | 479fb728-4aeb-42e3-b238-f04255514baa | 2026-08-05 | Warnings | M017 |
| Dealmed Burn | LIDOCAINE | Dealmed Medical Supplies, LLC. | 3b5f7ded-c275-4d7f-9fd4-539797d5507e | 2026-08-05 | Warnings | M017 |
| Lidocaine HCl | LIDOCAINE HCL | Topco Associates LLC | 584e1f35-4d99-9c85-e063-6294a90ab3d0 | 2026-08-05 | Warnings, Adverse reactions | M017 |
| Hempe HOT Muscle and Joint Gel | HEMPE | Healthcare International Research Limited | 5854a80e-c92b-3ff5-e063-6294a90a2d05 | 2026-08-05 | Warnings | M017 |
| Lidocaine Plantar Relief Roll-On | LIDOCAINE | Guangzhou Liuquanmiao Import & Export Trade Co., Ltd. | 585ccb4b-3bff-39b9-e063-6294a90a0e18 | 2026-08-05 | Warnings | M017 |
| Green MARVEL PAIN RELIEF | MENTHOL, CAMPHOR, METHYL SALICYLATE | Miramar Cosmetics, Inc DBA Miramar Lab | 9ff6e477-ef79-4a0c-9e21-8cae0e5d8810 | 2026-08-05 | Warnings | 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 |
| Wini By Locsanity Advanced Formula Muscle Joint Relief Balm | METHYL SALICYLATE,CAMPHOR,MENTHOL | Locsanity LLC | 5829b5d7-78d4-78a2-e063-6394a90a3dfc | 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 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 70983-027-01 | 70983002701 | 1 JAR in 1 BOX (70983-027-01) / 25 g in 1 JAR | 1 jar | 2023-02-24 | No | No | Current |