OTC - ACTIVE INGREDIENT SECTION
In Each Gram-Bacitracin Zinc 500 units
In Each Gram-Bacitracin Zinc 500 units
Purpose: First Aid Antibiotic
First Aid to help prevent infection in minor cuts, burns, scrapes
Keep out of the reach of children
Clean the affected area.
Apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1-3 times daily
May be covered with a sterile bandage.
inactive Ingredient: White Petrolatum
DO NOT USE
In the eyes. Over large areas of the body. If you are allergic to any of the ingredients due to the possibility of anaphylactic shock. Longer than 1 week unless directed by a doctor.
Stop use and ask a doctor before use in the case of deep puncture wounds, animal bites, or serious burns. If the condition persists or gets worse. If a rash or other allergic reaction develops.
If swallowed get medical help or contact a Poison Control Center immediately.
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68599-1184-1 | EA - Each | 68599-1184 | 2ad0f351-b034-4b7d-b878-a41590a76f22 | 1 | 2019-08-06 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 68599-1184 | 68599-1184-1 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| MINERAL OIL | T5L8T28FGP | IACT |
| PETROLATUM | 4T6H12BN9U | IACT |
| BACITRACIN ZINC | 89Y4M234ES | ACTIM |
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N000004-004 | PAREDRINE | HYDROXYAMPHETAMINE HYDROBROMIDE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 |
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | f41ea6bd6efb… |
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 |
|---|---|---|---|---|---|---|
| f18a058b-b4c8-1f61-e053-2995a90ae221 | 379f7a7a-1276-3aca-e054-00144ff88e88 | 2023-01-05 | Warnings | f18a058b-b4c8-1f61-e053-2995a90ae221 379f7a7a-1276-3aca-e054-00144ff88e88 |
Adverse event summaries are temporarily unavailable. Other product information remains available.