Dosage and administration
Apply to irritated areas as needed See package insert for instructions, warnings & cautions.
Apply to irritated areas as needed See package insert for instructions, warnings & cautions.
Benzocaine 9%
PEG 8, PEG 75, Glycerine, Tincture of Myrrh, Menthol, Phenol, Clove Oil, Methyl Salicylate, Peppermint Oil, Methyl Paraben, Propyl Paraben.
Apply to irritated areas as needed See package insert for instructions, warnings & cautions.
For temporary relief only.
Dist.by Infa-Lab Inc., Rockaway, NJ 07866
1996 INFA-LAB INC., Rockaway, NJ
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1547591 | benzocaine 9 % Oral Gel | PSN | 12 |
| 1547593 | Brace Relief 9 % Oral Gel | PSN | 12 |
| 1547593 | benzocaine 0.09 MG/MG Oral Gel [Brace Relief] | SBD | 12 |
| 1547591 | benzocaine 0.09 MG/MG Oral Gel | SCD | 12 |
| 1547591 | benzocaine 9 % Oral Gel | SY | 12 |
| 1547593 | Brace Relief 0.09 MG/MG Oral Gel | SY | 12 |
| 1547593 | Brace Relief 9 % Oral Gel | SY | 12 |
| Class | Version | Type | Effective |
|---|---|---|---|
| BENZOCAINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 362d7abb-94e6-4c60-9a58-266894157713 | Product name | 1 | 20231023 |
| 816b97af-edc5-4060-aff1-b814bdbcad50 | Product name | 1 | 20190415 |
| 419aab54-5d5a-4146-9453-026d4a9991be | Product name | 2 | 20170525 |
| 89dac932-b90a-4410-9ab1-84c53e57de25 | Product name | 1 | 20150316 |
| d723478e-ad4a-ec23-6bd7-cfe33e1e3840 | Product name | 1 | 20140508 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 60306-115-05 | 2022-04-11 | C162847 | 48780-1 | 9855e2a2-3c21-60a7-e053-dbdaa90a05bd | d7e57d67-4234-44a9-bbd3-72e99cd5bdb3 |
| 60306-115-05 | 2019-12-13 | C162847 | 48780-1 | 9855e2a2-3c21-60a7-e053-dbdaa90a05bd | d7e57d67-4234-44a9-bbd3-72e99cd5bdb3 |
| 60306-115-05 | 2019-11-27 | C162847 | 48780-1 | 9855e2a2-3c21-60a7-e053-dbdaa90a05bd | d7e57d67-4234-44a9-bbd3-72e99cd5bdb3 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 60306-115-05 | Brace Relief | 0.3 mL in 1 TUBE | GEL | 0.3 | 12 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Benzocaine | ACTIVE INGREDIENT | U3RSY48JW5 | 1 | |
| Benzocaine | ACTIVE MOIETY | U3RSY48JW5 | 1 | |
| Clove Oil | INACTIVE INGREDIENT | 578389D6D0 | 1 | |
| Glycerin | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| Menthol | INACTIVE INGREDIENT | L7T10EIP3A | 1 | |
| Methyl Salicylate | INACTIVE INGREDIENT | LAV5U5022Y | 1 | |
| Methylparaben | INACTIVE INGREDIENT | A2I8C7HI9T | 1 | |
| Myrrh | INACTIVE INGREDIENT | JC71GJ1F3L | 1 | |
| Peppermint Oil | INACTIVE INGREDIENT | AV092KU4JH | 1 | |
| Phenol | INACTIVE INGREDIENT | 339NCG44TV | 1 | |
| Polyethylene glycol 3350 | INACTIVE INGREDIENT | G2M7P15E5P | 1 | |
| Polyethylene glycol 400 | INACTIVE INGREDIENT | B697894SGQ | 1 | |
| Propylparaben | INACTIVE INGREDIENT | Z8IX2SC1OH | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 60306-115 | 60306-115-05 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Benzocaine | U3RSY48JW5 | ACTIB |
| Polyethylene glycol 400 | B697894SGQ | IACT |
| Polyethylene glycol 3350 | G2M7P15E5P | IACT |
| Glycerin | PDC6A3C0OX | IACT |
| Myrrh | JC71GJ1F3L | IACT |
| Menthol | L7T10EIP3A | IACT |
| Phenol | 339NCG44TV | IACT |
| Clove Oil | 578389D6D0 | IACT |
| Methyl Salicylate | LAV5U5022Y | IACT |
| Peppermint Oil | AV092KU4JH | IACT |
| Methylparaben | A2I8C7HI9T | IACT |
| Propylparaben | Z8IX2SC1OH | IACT |
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| Glycerin | GLYCERIN | PDC6A3C0OX | GEL / TOPICAL | 500 mg | ||
| Phenol | PHENOL | 339NCG44TV | INJECTION, SOLUTION / INTRAMUSCULAR | 75 mg | ||
| Menthol | MENTHOL | L7T10EIP3A | TABLET, ORALLY DISINTEGRATING / ORAL | 14 mg | ||
| Polyethylene glycol 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | GEL / VAGINAL | 1250 mg | ||
| Propylparaben | PROPYLPARABEN | Z8IX2SC1OH | POWDER, FOR SOLUTION / ORAL | 13 mg | ||
| Polyethylene glycol 3350 | POLYETHYLENE GLYCOL 3350 | G2M7P15E5P | TABLET / ORAL | 52 mg | ||
| Methyl Salicylate | METHYL SALICYLATE | LAV5U5022Y | GEL / TOPICAL | 0.05 %w/w | ||
| Polyethylene glycol 3350 | POLYETHYLENE GLYCOL 3350 | G2M7P15E5P | TABLET, CHEWABLE / ORAL | 15 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION, CONCENTRATE / ORAL | 200 mg/1ml | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | GEL / TOPICAL | 24 mg | ||
| Propylparaben | PROPYLPARABEN | Z8IX2SC1OH | SUSPENSION / ORAL | 64 mg | ||
| Polyethylene glycol 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | TABLET, FILM COATED / ORAL | 20 mg | ||
| Phenol | PHENOL | 339NCG44TV | DOUCHE / VAGINAL | 0.14 %w/w | ||
| Phenol | PHENOL | 339NCG44TV | INJECTION / INTRADERMAL | 0.25 %w/v | ||
| Clove Oil | CLOVE OIL | 578389D6D0 | SUSPENSION / ORAL | 0.1 mg/5ml | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SYRUP / ORAL | 16734 mg | ||
| Polyethylene glycol 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | TABLET, ORALLY DISINTEGRATING / ORAL | 2 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | LIQUID / ORAL | 2400 mg | ||
| Phenol | PHENOL | 339NCG44TV | INJECTION / SUBCUTANEOUS | 48 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | GEL / TRANSDERMAL | 500 mg | ||
| Propylparaben | PROPYLPARABEN | Z8IX2SC1OH | SUSPENSION, EXTENDED RELEASE / ORAL | 4 mg | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | SYRUP / ORAL | 81 mg | ||
| Phenol | PHENOL | 339NCG44TV | SOLUTION / INTRAVENOUS | 23 mg | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | SUSPENSION / ORAL | 388 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SUSPENSION / ORAL | 26208 mg | ||
| Menthol | MENTHOL | L7T10EIP3A | CONCENTRATE / ORAL | 0.05 mg/5ml | ||
| Phenol | PHENOL | 339NCG44TV | LIQUID / INTRAVENOUS | 0.5 %w/v | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SUSPENSION, EXTENDED RELEASE / ORAL | 2000 mg | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | TABLET, CHEWABLE / ORAL | 1.28 mg | ||
| Peppermint Oil | PEPPERMINT OIL | AV092KU4JH | SYRUP / ORAL | 120 mg | ||
| Peppermint Oil | PEPPERMINT OIL | AV092KU4JH | TABLET / ORAL | 28 mg | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | TABLET, EXTENDED RELEASE / ORAL | 0.17 mg | ||
| Phenol | PHENOL | 339NCG44TV | INJECTION / INTRALESIONAL | 0.5 %w/v | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | GEL / TRANSDERMAL | 500 mg | ||
| Polyethylene glycol 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | CAPSULE, DELAYED RELEASE / ORAL | 26 mg | ||
| Peppermint Oil | PEPPERMINT OIL | AV092KU4JH | SUSPENSION / ORAL | 100 mg/1ml | ||
| Phenol | PHENOL | 339NCG44TV | INJECTION / INTRAMUSCULAR | 48 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SUSPENSION/ DROPS / ORAL | 750 mg | ||
| Polyethylene glycol 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | GEL / VAGINAL | 1250 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | CAPSULE / ORAL | 3487 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | TABLET, COATED / ORAL | 1 mg | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | TABLET, CHEWABLE / ORAL | 1.28 mg | ||
| Propylparaben | PROPYLPARABEN | Z8IX2SC1OH | SOLUTION / ORAL | 100 mg | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | GEL / TOPICAL | 24 mg | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | GRANULE, FOR SUSPENSION / ORAL | 80 mg | ||
| Polyethylene glycol 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | SOLUTION, CONCENTRATE / ORAL | 2813 mg | ||
| Polyethylene glycol 3350 | POLYETHYLENE GLYCOL 3350 | G2M7P15E5P | TABLET, FILM COATED / ORAL | 20 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | CAPSULE, LIQUID FILLED / ORAL | 185 mg | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | CAPSULE, EXTENDED RELEASE / ORAL | 2 mg | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | CAPSULE / ORAL | 7 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | PASTE / ORAL | 3822 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | TABLET, CHEWABLE / ORAL | 12 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | TABLET, EXTENDED RELEASE / ORAL | 7 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | TABLET, COATED / ORAL | 1 mg | ||
| Phenol | PHENOL | 339NCG44TV | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 2 mg | ||
| Polyethylene glycol 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | TABLET / ORAL | 193 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SUSPENSION / ORAL | 26208 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SUSPENSION, EXTENDED RELEASE / ORAL | 2000 mg | ||
| Propylparaben | PROPYLPARABEN | Z8IX2SC1OH | SYRUP / ORAL | 40 mg | ||
| Phenol | PHENOL | 339NCG44TV | INJECTION, SOLUTION / INTRAVENOUS | 75 mg |
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 |
|---|---|---|---|---|---|---|
| Brace Relief | BENZOCAINE | InfaLab,Inc | d7e57d67-4234-44a9-bbd3-72e99cd5bdb3 | 2026-01-16 | Warnings | 60306-115-05 60306-115 60306011505 c4d6e935-9aaa-430e-ae72-51d4c84fcbf4 d7e57d67-4234-44a9-bbd3-72e99cd5bdb3 |
Adverse event summaries are temporarily unavailable. Other product information remains available.