Hemorrhoid, Fissure, ProctalgiaSuppositories
- Product NDC
- 84533-001
- 11-digit product format
- 845330001
- Labeler code
- 84533
- Product ID
- 84533-001_486510a7-f140-3a89-e063-6294a90a7bf7
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Carbon, Mirabilite, Peppermint oil, Borneol
- Dosage form
- SUPPOSITORY
- Route
- TOPICAL
- Labeler
- WU XI ZHONG ZHI WEI NA TECHNOLOGY CO., Ltd.
- Application
- M015
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-07-17
- Substance
- ACTIVATED CHARCOAL; BORNEOL; GLYCERIN; PEPPERMINT OIL; SODIUM SULFATE
- Active strength
- 1; 3; 8; .2; 2 g/100g; g/100g; g/100g; g/100g; g/100g
- Pharmacologic classes
- Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Food Additives [CS], Glycerol [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Hemorrhoid, Fissure, ProctalgiaSuppositories
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACTIVATED CHARCOAL | 1 g/100g |
| BORNEOL | 3 g/100g |
| GLYCERIN | 8 g/100g |
| PEPPERMINT OIL | .2 g/100g |
| SODIUM SULFATE | 2 g/100g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2P3VWU3H10, M89NIB437X, PDC6A3C0OX, AV092KU4JH, 0YPR65R21J |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 84533-001-01 | Hemorrhoid, Fissure, ProctalgiaSuppositories | 7 g in 1 BOX | SUPPOSITORY | 7 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 84533-001 | HEMORRHOID, FISSURE, PROCTALGIASUPPOSITORIES (CARBON, MIRABILITE, PEPPERMINT OIL, BORNEOL) SUPPOSITORY [WU XI ZHONG ZHI WEI NA TECHNOLOGY CO., LTD.] | 3 | Current NDC, 1 package rows | 20240723_1d40d16a-ee52-463a-e063-6394a90a6077.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 84533-001-01 | 84533000101 | 7 g in 1 BOX (84533-001-01) | 7 g | 2024-07-17 | No | No | Current |