warnings
WARNINGS For external use only. When using this product, avoid contact with eyes.
Pranicura II
- Product NDC
- 71831-003
- 11-digit product format
- 718310003
- Labeler code
- 71831
- Product ID
- 71831-003_cfa50395-1544-43ac-be86-295bcfb74dfd
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- GLYCERIN, KAOLIN, CALAMINE, MENTHOL
- Dosage form
- OINTMENT
- Route
- TOPICAL
- Labeler
- PRANICURA GROUP LLC
- Application
- part346
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2019-01-01
- Marketing end
- 0000-00-00
- Substance
- GLYCERIN; KAOLIN; MENTHOL; ZINC OXIDE
- Active strength
- 25 g/100g; g/100g; g/100g; g/100g
- Pharmacologic classes
- Allergens [CS], Cell-mediated Immunity [PE], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 71831-003 | D | Discontinued by firm | 2026-07-31 | ||
| excluded package | package | 71831-003 | 71831-003-01 | D | Discontinued by firm | 2026-07-31 |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Dynamo Wellness Delay MAX Wipe | DYNAMO WELLNESS DELAY MAX WIPE | Momentum Management LLC | 1f95e949-8f90-4de0-9097-24eadd404e22 | 2026-01-28 | Warnings | |
| Dynamo Wellness Delay Wipe | DYNAMO WELLNESS DELAY WIPE | Momentum Management LLC | b4319333-3c8d-40ab-ab70-99de1abbe871 | 2026-01-08 | Warnings | |
| Xyralid Hemorrhoidal | HEMORRHOIDAL SUPPOSITORIES | Innovus Pharmaceuticals, Inc. | 8a885822-42e7-44e0-82d6-fa967123866e | 2018-05-03 | Warnings |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 71831-003-01 | 71831000301 | 60 g in 1 JAR (71831-003-01) | 60 g | 2020-04-15 | 0000-00-00 | No | No | Current |