OFTAL-MYCIN LUBRICANT OPHTHALMIC
- Product NDC
- 48201-301
- 11-digit product format
- 482010301
- Labeler code
- 48201
- Product ID
- 48201-301_422c0915-37ab-dfd4-e063-6294a90ac5d3
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- LIGHT MINERAL, WHITE PETROLATUM
- Dosage form
- OINTMENT
- Route
- OPHTHALMIC
- Labeler
- GRANDALL DISTRIBUTING, LLC
- Application
- M014
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-12-18
- Substance
- WHITE PETROLATUM; LIGHT MINERAL OIL
- Active strength
- 83; 15 g/100g; g/100g
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- OFTAL-MYCIN LUBRICANT OPHTHALMIC
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| WHITE PETROLATUM | 83 g/100g |
| LIGHT MINERAL OIL | 15 g/100g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| B6E5W8RQJ4 | Internal UNII lookup |
| N6K5787QVP | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 746083 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 298db04a-21a9-e46e-e063-6294a90acee2 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 48201-301-11 | OFTAL-MYCIN LUBRICANT OPHTHALMIC | 3.5 g in 1 BOTTLE | OINTMENT | 3.5 | 4 |
DailyMed Dashboard NDC Coverage#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| HANCHOBIT Lemon Turmeric Kojic Acid Brightening | GLYCERIN | HANCHOYEANBIOTEC Co.,Ltd. | 2ded8f31-d72a-d123-e063-6294a90a2856 | 2025-11-27 | Warnings | M014 |
| XIMONTH Wart Remover | GLYCERIN | Shantou Ximonth Biotechnology Co., Ltd. | 337d4d37-c2d6-44d3-e063-6294a90a77ce | 2025-11-26 | Warnings | M014 |
| Swimmers Ear | CLEARCANAL | Neilmed Pharmaceuticals Inc. | 43778b02-e90b-36b7-e063-6394a90ab62b | 2025-11-13 | Warnings | M014 |
| Hand Sanitizer | ALCOHOL | Charlotte Products Ltd. | 1fbfe3f9-e0db-a3a2-e063-6294a90ab6aa | 2025-10-28 | Warnings | M014 |
| Carbamide peroxide 6.5% | EARWAX REMOVAL KIT | Allegiant Health | 54515e9d-2225-4875-a1cf-a24a823300dd | 2025-10-28 | Warnings | M014 |
| OFTAL-MYCIN LUBRICANT OPHTHALMIC | LIGHT MINERAL, WHITE PETROLATUM | GRANDALL DISTRIBUTING, LLC | 298db04a-21a9-e46e-e063-6294a90acee2 | 2025-10-27 | Warnings | M014 48201-301 |
| Debrox Swimmers Ear | ISOPROPYL ALCOHOL | Medtech Products Inc. | b5d57c7b-8315-4260-967e-38fdd54e2a9c | 2025-10-23 | Warnings | M014 |
| Family Care Earwax Removal | CARBAMIDE PEROXIDE | United Exchange Corp. | 958741f5-47c1-339c-e053-2a95a90a3f5f | 2025-10-22 | Warnings | M014 |
| GoodSense Ear Wax Removal Kit | CARBAMIDE PEROXIDE | Geiss, Destin & Dunn, Inc | 31ea324f-a9a1-7865-e063-6294a90a92e8 | 2025-09-19 | Warnings | M014 |
| blue goo NERVE EASE Pain RELIEF Topical Analgesic | LIDOCAINE HCL 4%, MENTHOL 1% | Garcoa, Inc. | 619d5c87-636c-407d-909e-c38512dcd553 | 2025-09-10 | Warnings | M014 |
| DEBROX | CARBAMIDE PEROXIDE | A-S Medication Solutions | 8d6f1769-eb44-4bde-b3fa-3ff4658b7dd1 | 2025-09-03 | Warnings | M014 |
| Auralyt | CARBAMIDE PEROXIDE | Menper Distributors, Inc | 95920b87-941f-48cb-850c-40d2735596d4 | 2025-07-22 | Warnings | M014 |
| hydrocortisone | HYDROCORTISONE | NuCare Pharmaceuticals,Inc. | a0fde5c9-afb2-76a9-e053-2995a90af3e8 | 2025-07-21 | Warnings | M014 |
| Healthy Ears | CARBIDE PEROXIDE | Vitamex USA, Corp | 25953441-cd8e-5038-e063-6294a90ae401 | 2025-06-23 | Warnings | M014 |
| WaxRx Ear Wax Removal Aid Drops | CARBAMIDE PEROXIDE | DOCTOR EASY MEDICAL PRODUCTS, LLC | 7e08cd86-7ae4-7d12-e053-2991aa0a4cba | 2025-05-01 | Warnings | M014 |
| Meijer Earwax Removal Drops | CARBAMIDE PEROXIDE | Meijer Distribution Inc | 900108c6-0324-644a-e053-2a95a90a3b2b | 2025-02-28 | Warnings | M014 |
| Tech Care Earwax Removal Kit | CARBAMIDE PEROXIDE | Warner Tech-care Products, LLC | 5851c1f6-c15b-447c-b495-3707e7a12bdb | 2025-02-28 | Warnings | M014 |
| Tech Care Earwax Removal Drops | CARBAMIDE PEROXIDE | Warner Tech-care Products, LLC | 1c97783b-dcdf-4f95-8516-0d7f197cbc27 | 2025-02-28 | Warnings | M014 |
| TopCare Earwax Removal Kit | CARBAMIDE PEROXIDE | TOPCO ASSOCIATES LLC | 890cc9b6-41a5-480a-bc94-45c8d4fdeef3 | 2025-02-28 | Warnings | M014 |
| Audiologists Choice Earwax Removal Aid Drops | CARBAMIDE PEROXIDE | Oaktree Products Inc | 2922dde2-d082-437b-8f51-4a91ced20a58 | 2025-02-28 | Warnings | M014 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 746083 | mineral oil 15 % / petrolatum 83 % Ophthalmic Ointment | PSN | 298db04a-21a9-e46e-e063-6294a90acee2 | 4 |
| 746083 | mineral oil 0.15 MG/MG / petrolatum 0.83 MG/MG Ophthalmic Ointment | SCD | 298db04a-21a9-e46e-e063-6294a90acee2 | 4 |
| 746083 | mineral oil 15 % / petrolatum, white 83 % Ophthalmic Ointment | SY | 298db04a-21a9-e46e-e063-6294a90acee2 | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 48201-301-11 | 48201030111 | 3.5 g in 1 BOTTLE (48201-301-11) | 3.5 g | 2024-12-18 | No | No | Current |