Rotex
- Product NDC
- 69379-038
- 11-digit product format
- 693790038
- Labeler code
- 69379
- Product ID
- 69379-038_1c834710-1287-3266-e054-00144ff8d46c
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Rotex Pain Relieving Cream
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Home Aide Diagnostics, Inc.
- Application
- part348
- Marketing category
- OTC MONOGRAPH NOT FINAL
- Marketing start
- 2015-08-10
- Marketing end
- 0000-00-00
- Substance
- METHYL SALICYLATE; MENTHOL; CAPSAICIN
- Active strength
- 35 g/100g; g/100g; g/100g
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 473d070d-1c38-488e-b991-c4d1bf45aab8 | Product name | 1 | 20210201 |
| dea2eded-d1e7-46bb-9a3d-f8dc20de6277 | Product name | 1 | 20190408 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 69379-038-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-7a1a-f424-e053-dadaa90a57ce | Rotex Pain Relieving Cream |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69379-038-01 | Rotex | 120 g in 1 BOTTLE, PLASTIC | CREAM | 120 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 69379-038-01 | GM - Gram | 69379-038 | cdf21bf8-e16c-4804-b79f-f42496a7cfba | 1 | 2015-11-12 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| CAPSAICIN | ACTIVE INGREDIENT | S07O44R1ZM | ROTEX (ROTEX PAIN RELIEVING CREAM) CREAM [HOME AIDE DIAGNOSTICS, INC.] | 1 | |
| MENTHOL | ACTIVE INGREDIENT | L7T10EIP3A | ROTEX (ROTEX PAIN RELIEVING CREAM) CREAM [HOME AIDE DIAGNOSTICS, INC.] | 1 | |
| METHYL SALICYLATE | ACTIVE INGREDIENT | LAV5U5022Y | ROTEX (ROTEX PAIN RELIEVING CREAM) CREAM [HOME AIDE DIAGNOSTICS, INC.] | 1 | |
| CAPSAICIN | ACTIVE MOIETY | S07O44R1ZM | ROTEX (ROTEX PAIN RELIEVING CREAM) CREAM [HOME AIDE DIAGNOSTICS, INC.] | 1 | |
| MENTHOL | ACTIVE MOIETY | L7T10EIP3A | ROTEX (ROTEX PAIN RELIEVING CREAM) CREAM [HOME AIDE DIAGNOSTICS, INC.] | 1 | |
| SALICYLIC ACID | ACTIVE MOIETY | O414PZ4LPZ | ROTEX (ROTEX PAIN RELIEVING CREAM) CREAM [HOME AIDE DIAGNOSTICS, INC.] | 1 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | ROTEX (ROTEX PAIN RELIEVING CREAM) CREAM [HOME AIDE DIAGNOSTICS, INC.] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1660761 | capsaicin 0.038 % / menthol 4 % / methyl salicylate 35 % Topical Cream | PSN | 1c834710-1286-3266-e054-00144ff8d46c | 1 |
| 1660761 | capsaicin 0.38 MG/ML / menthol 40 MG/ML / methyl salicylate 350 MG/ML Topical Cream | SCD | 1c834710-1286-3266-e054-00144ff8d46c | 1 |
| 1660761 | capsaicin 0.038 % / menthol 4 % / methyl salicylate 35 % Topical Cream | SY | 1c834710-1286-3266-e054-00144ff8d46c | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Status |
|---|---|---|---|---|
| 69379-038-01 | 69379003801 | 120 g in 1 BOTTLE, PLASTIC | 120 g | Historical |