Eagle Brand
- Product NDC
- 43405-012
- 11-digit product format
- 434050012
- Labeler code
- 43405
- Product ID
- 43405-012_4e5d63b2-eefe-e63d-e063-6394a90aa14e
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- camphor, menthol
- Dosage form
- OIL
- Route
- TOPICAL
- Labeler
- Borden Company (Private) Limited
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-11-01
- Substance
- CAMPHOR (SYNTHETIC); MENTHOL
- Active strength
- 2.2; 14 g/100mL; g/100mL
- 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
- Eagle Brand
- Brand name suffix
- Medicated Roll On Refresh
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| CAMPHOR (SYNTHETIC) | 2.2 g/100mL |
| MENTHOL | 14 g/100mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 5TJD82A1ET | Internal UNII lookup |
| L7T10EIP3A | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 2672336 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 091451fb-e30a-0012-e063-6394a90a3ba8 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 43405-012-08 | Eagle BrandMedicated Roll On Refresh | 1 in 1 BOX | OIL | 1 | 2 | |
| 43405-012-08 | Eagle BrandMedicated Roll On Refresh | 8 mL in 1 BOTTLE, GLASS | OIL | 8 | 2 |
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 |
|---|---|---|---|---|---|---|
| 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 |
| IceQuake Analgestic White | METHYL SALICYLATE, MENTHOL | Southern Sales & Service, Inc. | 54e5dcd5-9987-488d-a758-d0e76d155182 | 2023-11-29 | Warnings | M017 |
| Icequake Coldn Hot medicated patch | MENTHOL | Southern Sales & Service, Inc. | 89202c52-9eb7-4e5a-a709-4a66ab0d3a72 | 2023-11-29 | Warnings | M017 |
| IceQuake Lidocaine Analgesic | LIDOCAINE HYDROCHLORIDE | Southern Sales & Service, Inc. | 9089cb78-e9f8-4437-a767-df809a114c4b | 2023-11-29 | Warnings | M017 |
| Ice Quake Muscle Rub Blue | MENTHOL | Southern Sales & Service, Inc. | 5180f6a3-58f1-4c50-a33b-7d85a3c1b99b | 2023-11-29 | Warnings | M017 |
| Discount Drug Mart Extra Strength Itch Stopping | DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE | Discount Drug Mart | 8579df23-ac07-9df8-e053-2991aa0a8bbb | 2023-11-29 | Warnings | M017 |
| Satohap | METHYL SALICYLATE, DL-CAMPHOR, L-MENTHOL | Sato Pharmaceutical Co., Ltd. | 3a2fc8ae-f1ac-4c64-8e75-d5fdb141aecf | 2023-11-28 | Warnings | M017 |
| Poli-A | HYDROCORTISONE ACETATE | Sato Pharmaceutical Co., Ltd. | e27a3840-d9de-4bd0-ad75-8a151bd12b83 | 2023-11-28 | Warnings | M017 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2672336 | camphor 2.2 % / menthol 14 % Topical Oil | PSN | 091451fb-e30a-0012-e063-6394a90a3ba8 | 2 |
| 2672336 | camphor 22 MG/ML / menthol 140 MG/ML Topical Oil | SCD | 091451fb-e30a-0012-e063-6394a90a3ba8 | 2 |
| 2672336 | camphor 2.2 % / menthol 14 % Topical Oil | SY | 091451fb-e30a-0012-e063-6394a90a3ba8 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 43405-012-08 | 43405001208 | 1 BOTTLE, GLASS in 1 BOX (43405-012-08) / 8 mL in 1 BOTTLE, GLASS | 2023-11-01 | No | No | Current |