Proctofoam
- Product NDC
- 21695-982
- 11-digit product format
- 216950982
- Labeler code
- 21695
- Product ID
- 21695-982_14e43813-665c-4cef-b3b1-60eafc880f41
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- hydrocortisone acetate and pramoxine hydrochloride
- Dosage form
- AEROSOL, FOAM
- Route
- TOPICAL
- Labeler
- Rebel Distributors Corp
- Application
- ANDA086195
- Marketing category
- ANDA
- Marketing start
- 1978-07-26
- Marketing end
- 0000-00-00
- Substance
- HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE
- Active strength
- 100 mg/10g; mg/10g
- Pharmacologic classes
- Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 21695-982-10 | ProctofoamHC | 1 in 1 CARTON | AEROSOL, FOAM | 1 | | 1 |
| 21695-982-10 | ProctofoamHC | 10 g in 1 CONTAINER | AEROSOL, FOAM | 10 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| hydrocortisone acetate | ACTIVE INGREDIENT | 3X7931PO74 | PROCTOFOAM HC (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) AEROSOL, FOAM [REBEL DISTRIBUTORS CORP] | 1 | |
| pramoxine hydrochloride | ACTIVE INGREDIENT | 88AYB867L5 | PROCTOFOAM HC (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) AEROSOL, FOAM [REBEL DISTRIBUTORS CORP] | 1 | |
| hydrocortisone | ACTIVE MOIETY | WI4X0X7BPJ | PROCTOFOAM HC (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) AEROSOL, FOAM [REBEL DISTRIBUTORS CORP] | 1 | |
| pramoxine | ACTIVE MOIETY | 068X84E056 | PROCTOFOAM HC (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) AEROSOL, FOAM [REBEL DISTRIBUTORS CORP] | 1 | |
| cetyl alcohol | INACTIVE INGREDIENT | 936JST6JCN | PROCTOFOAM HC (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) AEROSOL, FOAM [REBEL DISTRIBUTORS CORP] | 1 | |
| isobutane | INACTIVE INGREDIENT | BXR49TP611 | PROCTOFOAM HC (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) AEROSOL, FOAM [REBEL DISTRIBUTORS CORP] | 1 | |
| methylparaben | INACTIVE INGREDIENT | A2I8C7HI9T | PROCTOFOAM HC (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) AEROSOL, FOAM [REBEL DISTRIBUTORS CORP] | 1 | |
| propane | INACTIVE INGREDIENT | T75W9911L6 | PROCTOFOAM HC (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) AEROSOL, FOAM [REBEL DISTRIBUTORS CORP] | 1 | |
| propylene glycol | INACTIVE INGREDIENT | 6DC9Q167V3 | PROCTOFOAM HC (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) AEROSOL, FOAM [REBEL DISTRIBUTORS CORP] | 1 | |
| propylparaben | INACTIVE INGREDIENT | Z8IX2SC1OH | PROCTOFOAM HC (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) AEROSOL, FOAM [REBEL DISTRIBUTORS CORP] | 1 | |
| trolamine | INACTIVE INGREDIENT | 9O3K93S3TK | PROCTOFOAM HC (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) AEROSOL, FOAM [REBEL DISTRIBUTORS CORP] | 1 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | PROCTOFOAM HC (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) AEROSOL, FOAM [REBEL DISTRIBUTORS CORP] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 21695-982 | PROCTOFOAM HC (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) AEROSOL, FOAM [REBEL DISTRIBUTORS CORP] | 1 | Legacy NDC, 2 package rows | 20111118_14e43813-665c-4cef-b3b1-60eafc880f41.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 21695-982-10 | 21695098210 | 1 in 1 CARTON | Historical |