phenylephrine hydrochloride
- Product NDC
- 0363-0394
- 11-digit product format
- 003630394
- Labeler code
- 0363
- Product ID
- 0363-0394_fab7f59f-aa4d-4a8b-9d22-cd475ccfbf20
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- phenylephrine hydrochloride
- Dosage form
- SUPPOSITORY
- Route
- RECTAL
- Labeler
- Walgreen Company
- Application
- part346
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2005-12-01
- Marketing end
- 0000-00-00
- Substance
- COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE; SHARK LIVER OIL
- Active strength
- 2077 mg/1; mg/1; mg/1
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0363-0394-53 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-ca14-621f-e053-dbdaa90a74ad | DRUG FACTS |
| 0363-0394-62 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-ca14-621f-e053-dbdaa90a74ad | DRUG FACTS |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0363-0394-53 | phenylephrine hydrochloride | 12 in 1 BOX | SUPPOSITORY | 12 | 1 | |
| 0363-0394-62 | phenylephrine hydrochloride | 24 in 1 BOX | SUPPOSITORY | 24 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0363-0394-53 | EA - Each | 0363-0394 | 90984028-8685-48c0-8cb6-d5c09e431ba5 | 1 | 2012-07-24 |
| 0363-0394-62 | EA - Each | 0363-0394 | 804935f2-8da3-47fa-afb2-ca9f4350c625 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| cocoa butter | ACTIVE INGREDIENT | 512OYT1CRR | PHENYLEPHRINE HYDROCHLORIDE SUPPOSITORY [WALGREEN COMPANY] | 1 | |
| phenylephrine hydrochloride | ACTIVE INGREDIENT | 04JA59TNSJ | PHENYLEPHRINE HYDROCHLORIDE SUPPOSITORY [WALGREEN COMPANY] | 1 | |
| shark liver oil | ACTIVE INGREDIENT | 4B24275HEU | PHENYLEPHRINE HYDROCHLORIDE SUPPOSITORY [WALGREEN COMPANY] | 1 | |
| cocoa butter | ACTIVE MOIETY | 512OYT1CRR | PHENYLEPHRINE HYDROCHLORIDE SUPPOSITORY [WALGREEN COMPANY] | 1 | |
| phenylephrine | ACTIVE MOIETY | 1WS297W6MV | PHENYLEPHRINE HYDROCHLORIDE SUPPOSITORY [WALGREEN COMPANY] | 1 | |
| shark liver oil | ACTIVE MOIETY | 4B24275HEU | PHENYLEPHRINE HYDROCHLORIDE SUPPOSITORY [WALGREEN COMPANY] | 1 | |
| methylparaben | INACTIVE INGREDIENT | A2I8C7HI9T | PHENYLEPHRINE HYDROCHLORIDE SUPPOSITORY [WALGREEN COMPANY] | 1 | |
| propylparaben | INACTIVE INGREDIENT | Z8IX2SC1OH | PHENYLEPHRINE HYDROCHLORIDE SUPPOSITORY [WALGREEN COMPANY] | 1 | |
| starch, corn | INACTIVE INGREDIENT | O8232NY3SJ | PHENYLEPHRINE HYDROCHLORIDE SUPPOSITORY [WALGREEN COMPANY] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 259093 | cocoa butter 85.5 % / phenylephrine HCl 0.25 % / shark liver oil 3 % Rectal Suppository | PSN | ee2ba10c-dce9-46fc-96a2-ff0d119cd1cb | 1 |
| 259093 | cocoa butter 0.855 MG/MG / phenylephrine 0.0025 MG/MG / shark liver oil 0.03 MG/MG Rectal Suppository | SCD | ee2ba10c-dce9-46fc-96a2-ff0d119cd1cb | 1 |
| 259093 | cocoa butter 85.5 % / phenylephrine 0.25 % / shark liver oil preparation 3 % Rectal Suppository | SY | ee2ba10c-dce9-46fc-96a2-ff0d119cd1cb | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 0363-0394-53 | 00363039453 | 12 in 1 BOX | Historical |
| 0363-0394-62 | 00363039462 | 24 in 1 BOX | Historical |