Dibucaine Topical Anesthetic 1% Hemorrhoidal
- Product NDC
- 0536-1211
- 11-digit product format
- 005361211
- Labeler code
- 0536
- Product ID
- 0536-1211_364c388d-adc9-9763-e063-6294a90a77cd
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- DIBUCAINE
- Dosage form
- OINTMENT
- Route
- TOPICAL
- Labeler
- Rugby Laboratories Inc.
- Application
- M015
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2019-08-19
- Substance
- DIBUCAINE
- Active strength
- 10 mg/g
- Pharmacologic classes
- Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Dibucaine Topical Anesthetic 1% Hemorrhoidal
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DIBUCAINE | 10 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | L6JW2TJG99 |
| Rxcui | 198601 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0536-1211-95 | Dibucaine Topical Anesthetic 1% Hemorrhoidal | 1 in 1 BOX | OINTMENT | 1 | | 6 |
| 0536-1211-95 | Dibucaine Topical Anesthetic 1% Hemorrhoidal | 28 g in 1 TUBE | OINTMENT | 28 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0536-1211 | DIBUCAINE TOPICAL ANESTHETIC 1% HEMORRHOIDAL (DIBUCAINE) OINTMENT [RUGBY LABORATORIES INC.] | 5 | Current NDC, Legacy NDC, 2 package rows | 20231025_f23c8cd1-98f9-41cd-84d4-cf01c2ede29a.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 |
|---|
| 0536-1211-95 | 00536121195 | 1 TUBE in 1 BOX (0536-1211-95) / 28 g in 1 TUBE | 1 tube | 2019-08-19 | 0000-00-00 | No | No | Current |