PREPARATION H
- Product NDC
- 0573-2883
- 11-digit product format
- 005732883
- Labeler code
- 0573
- Product ID
- 0573-2883_12ad4740-7bea-f822-e063-6394a90a0e38
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- cocoa butter, phenylephrine hydrochloride
- Dosage form
- SUPPOSITORY
- Route
- RECTAL
- Labeler
- Haleon US Holdings LLC
- Application
- M015
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2004-01-05
- Substance
- COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 2211; 6.25 mg/1; 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 |
|---|
| COCOA BUTTER | 2211 mg/1 |
| PHENYLEPHRINE HYDROCHLORIDE | 6.25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 512OYT1CRR, 04JA59TNSJ |
| Rxcui | 1438497 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| COCOA BUTTER | ACTIVE INGREDIENT | 512OYT1CRR | PREPARATION H (COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE) SUPPOSITORY [PFIZER CONSUMER HEALTHCARE] | 10 | |
| PHENYLEPHRINE HYDROCHLORIDE | ACTIVE INGREDIENT | 04JA59TNSJ | PREPARATION H (COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE) SUPPOSITORY [PFIZER CONSUMER HEALTHCARE] | 10 | |
| COCOA BUTTER | ACTIVE MOIETY | 512OYT1CRR | PREPARATION H (COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE) SUPPOSITORY [PFIZER CONSUMER HEALTHCARE] | 10 | |
| PHENYLEPHRINE | ACTIVE MOIETY | 1WS297W6MV | PREPARATION H (COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE) SUPPOSITORY [PFIZER CONSUMER HEALTHCARE] | 10 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | PREPARATION H (COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE) SUPPOSITORY [PFIZER CONSUMER HEALTHCARE] | 10 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | PREPARATION H (COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE) SUPPOSITORY [PFIZER CONSUMER HEALTHCARE] | 10 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | PREPARATION H (COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE) SUPPOSITORY [PFIZER CONSUMER HEALTHCARE] | 10 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0573-2883 | PREPARATION H (COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE) SUPPOSITORY [HALEON US HOLDINGS LLC] | 18 | Current NDC, Legacy NDC, 10 package rows | 20240303_a23ded81-78ba-c199-a8f0-aaf360b216ff.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0573-2883-10 | 00573288310 | 12 BLISTER PACK in 1 CARTON (0573-2883-10) > 1 SUPPOSITORY in 1 BLISTER PACK | 12 blister pack | 2004-01-05 | 0000-00-00 | No | No | Current |
| 0573-2883-11 | 00573288311 | 12 BLISTER PACK in 1 CARTON (0573-2883-11) > 1 SUPPOSITORY in 1 BLISTER PACK | 12 blister pack | 2004-01-05 | 0000-00-00 | No | No | Current |
| 0573-2883-20 | 00573288320 | 24 BLISTER PACK in 1 CARTON (0573-2883-20) > 1 SUPPOSITORY in 1 BLISTER PACK | 24 blister pack | 2004-01-05 | 0000-00-00 | No | No | Current |
| 0573-2883-30 | 00573288330 | 48 BLISTER PACK in 1 CARTON (0573-2883-30) > 1 SUPPOSITORY in 1 BLISTER PACK | 48 blister pack | 2004-01-05 | 0000-00-00 | No | No | Current |
| 0573-2883-55 | 00573288355 | 56 BLISTER PACK in 1 CARTON (0573-2883-55) > 1 SUPPOSITORY in 1 BLISTER PACK | 56 blister pack | 2004-01-05 | 0000-00-00 | No | No | Current |