Formulation R
- Product NDC
- 0713-0535
- 11-digit product format
- 007130535
- Labeler code
- 0713
- Product ID
- 0713-0535_17cecb0a-0c16-cdda-744e-a3dea9333e1e
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Phenylephrine Hydrochloride, Hydrogenate Palm Kernel Oil
- Dosage form
- SUPPOSITORY
- Route
- RECTAL
- Labeler
- G&W Laboratories, Inc.
- Application
- part346
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2002-06-24
- Marketing end
- 0000-00-00
- Substance
- PHENYLEPHRINE HYDROCHLORIDE; HYDROGENATED PALM KERNEL OIL
- Active strength
- 3 mg/1; mg/1
- NDC exclude flag
- E
- Listing certified through
- 2018-12-31
- 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 |
|---|
| 0713-0535-12 | Formulation R | 12 in 1 CARTON | SUPPOSITORY | 12 | | 1 |
| 0713-0535-24 | Formulation R | 24 in 1 CARTON | SUPPOSITORY | 24 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Hydrogenated Palm Kernel Oil | ACTIVE INGREDIENT | FM8D1RE2VP | FORMULATION R (PHENYLEPHRINE HYDROCHLORIDE, HYDROGENATE PALM KERNEL OIL) SUPPOSITORY [G&W LABORATORIES, INC.] | 1 | |
| Phenylephrine Hydrochloride | ACTIVE INGREDIENT | 04JA59TNSJ | FORMULATION R (PHENYLEPHRINE HYDROCHLORIDE, HYDROGENATE PALM KERNEL OIL) SUPPOSITORY [G&W LABORATORIES, INC.] | 1 | |
| Hydrogenated Palm Kernel Oil | ACTIVE MOIETY | FM8D1RE2VP | FORMULATION R (PHENYLEPHRINE HYDROCHLORIDE, HYDROGENATE PALM KERNEL OIL) SUPPOSITORY [G&W LABORATORIES, INC.] | 1 | |
| Phenylephrine | ACTIVE MOIETY | 1WS297W6MV | FORMULATION R (PHENYLEPHRINE HYDROCHLORIDE, HYDROGENATE PALM KERNEL OIL) SUPPOSITORY [G&W LABORATORIES, INC.] | 1 | |
| Cod Liver Oil | INACTIVE INGREDIENT | BBL281NWFG | FORMULATION R (PHENYLEPHRINE HYDROCHLORIDE, HYDROGENATE PALM KERNEL OIL) SUPPOSITORY [G&W LABORATORIES, INC.] | 1 | |
| Methylparaben | INACTIVE INGREDIENT | A2I8C7HI9T | FORMULATION R (PHENYLEPHRINE HYDROCHLORIDE, HYDROGENATE PALM KERNEL OIL) SUPPOSITORY [G&W LABORATORIES, INC.] | 1 | |
| Propylparaben | INACTIVE INGREDIENT | Z8IX2SC1OH | FORMULATION R (PHENYLEPHRINE HYDROCHLORIDE, HYDROGENATE PALM KERNEL OIL) SUPPOSITORY [G&W LABORATORIES, INC.] | 1 | |
| Starch, Corn | INACTIVE INGREDIENT | O8232NY3SJ | FORMULATION R (PHENYLEPHRINE HYDROCHLORIDE, HYDROGENATE PALM KERNEL OIL) SUPPOSITORY [G&W LABORATORIES, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0713-0535 | FORMULATION R (PHENYLEPHRINE HYDROCHLORIDE, HYDROGENATE PALM KERNEL OIL) SUPPOSITORY [G&W LABORATORIES, INC.] | 1 | Legacy NDC, 2 package rows | 20120203_a95c678f-84f7-13db-f5b5-05d4d8761fc4.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 0713-0535-12 | 00713053512 | 12 in 1 CARTON | Historical |
| 0713-0535-24 | 00713053524 | 24 in 1 CARTON | Historical |