PREPARATION H
- Product NDC
- 0573-1378
- 11-digit product format
- 005731378
- Labeler code
- 0573
- Product ID
- 0573-1378_331041bf-cde7-dceb-e063-6394a90a65e0
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Phenylephrine hydrochloride
- Dosage form
- SUPPOSITORY
- Route
- RECTAL
- Labeler
- Haleon US Holdings LLC
- Application
- M015
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2022-12-16
- Substance
- PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 6.25 mg/1
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- PREPARATION H
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PHENYLEPHRINE HYDROCHLORIDE | 6.25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 04JA59TNSJ |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0573-1378-00 | PREPARATION H | 1 in 1 BLISTER PACK | SUPPOSITORY | 1 | | 4 |
| 0573-1378-00 | PREPARATION H | 48 in 1 CARTON | SUPPOSITORY | 48 | | 4 |
| 0573-1378-01 | PREPARATION H | 12 in 1 CARTON | SUPPOSITORY | 12 | | 4 |
| 0573-1378-01 | PREPARATION H | 1 in 1 BLISTER PACK | SUPPOSITORY | 1 | | 4 |
| 0573-1378-06 | PREPARATION H | 1 in 1 BLISTER PACK | SUPPOSITORY | 1 | | 4 |
| 0573-1378-06 | PREPARATION H | 24 in 1 CARTON | SUPPOSITORY | 24 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0573-1378 | PREPARATION H (PHENYLEPHRINE HYDROCHLORIDE) SUPPOSITORY [HALEON US HOLDINGS LLC] | 4 | Current NDC, 6 package rows | 20250419_96d2e0e7-2de0-4660-9ffd-9edb2ad224d8.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0573-1378-00 | 00573137800 | 48 BLISTER PACK in 1 CARTON (0573-1378-00) / 1 SUPPOSITORY in 1 BLISTER PACK | 48 blister pack | 2022-12-16 | No | No | Current |
| 0573-1378-01 | 00573137801 | 12 BLISTER PACK in 1 CARTON (0573-1378-01) / 1 SUPPOSITORY in 1 BLISTER PACK | 12 blister pack | 2022-12-16 | No | No | Current |
| 0573-1378-06 | 00573137806 | 24 BLISTER PACK in 1 CARTON (0573-1378-06) / 1 SUPPOSITORY in 1 BLISTER PACK | 24 blister pack | 2022-12-16 | No | No | Current |