warnings
Allergy Alert do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics
4X Medicated Severe Toothache and Gum Gel
openFDA label record#
This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
Verified complete openFDA source JSON
- Brand name
- 4X Medicated Severe Toothache and Gum Gel
- Generic name
- BENZOCAINE
- Manufacturer
- Rite Aid
- Product type
- HUMAN OTC DRUG
- SPL set ID
- 99703bf4-f169-5e05-e053-2995a90afab4
- SPL ID
- 437ffe13-51f2-ebce-e063-6394a90a0185
- Version
- 13
- Effective date
- 2025-11-13
- Source export date
- 2026-09-28
- Source partition
- 2
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/f7d2b6e3f8600cd856280ab55a9c6fa54a642647191d164f9d1110e89f3f4097/drug-label-0002-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:15:21
| Harmonized routes |
|---|
| ORAL |
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| application number | M022 | openfda.application_number | |
| brand name | 4X Medicated Severe Toothache and Gum Gel | openfda.brand_name | |
| generic name | BENZOCAINE | openfda.generic_name | |
| manufacturer name | Rite Aid | openfda.manufacturer_name | |
| ndc | package | 11822-0615-9 | openfda.package_ndc |
| ndc | product | 11822-0615 | openfda.product_ndc |
| ndc11 | package | 11822061509 | derived:openfda.package_ndc |
| rxcui | 2369638 | openfda.rxcui | |
| spl id | 437ffe13-51f2-ebce-e063-6394a90a0185 | id | |
| spl set id | 99703bf4-f169-5e05-e053-2995a90afab4 | set_id | |
| unii | U3RSY48JW5 | openfda.unii | |
| unii | L7T10EIP3A | openfda.unii | |
| unii | F5UM2KM3W7 | openfda.unii | |
| unii | 86Q357L16B | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.