Orajel 3X Medicated For All Mouth Sores
- Product NDC
- 10237-783
- 11-digit product format
- 102370783
- Labeler code
- 10237
- Product ID
- 10237-783_45c2f5a1-7e8a-1fbd-e063-6394a90ab88f
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Benzocaine, Menthol, Zinc Chloride
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Church & Dwight Co., Inc.
- Application
- M022
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2019-11-01
- Substance
- BENZOCAINE; MENTHOL; ZINC CHLORIDE
- Active strength
- 200; 1; 1.5 mg/g; mg/g; mg/g
- Pharmacologic classes
- Allergens [CS], Cell-mediated Immunity [PE], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
- 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
- Orajel 3X Medicated For All Mouth Sores
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| BENZOCAINE | 200 mg/g |
| MENTHOL | 1 mg/g |
| ZINC CHLORIDE | 1.5 mg/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| U3RSY48JW5 | Internal UNII lookup |
| L7T10EIP3A | Internal UNII lookup |
| 86Q357L16B | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 2266762 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 99b589ac-9833-fb60-e053-2995a90a0935 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| f47a510b-6679-4664-b2d6-47b5c4afe7cc | Product name | 4 | 20260217 |
| 030ce964-9b2d-45aa-b5d3-f78ce03ef61c | Product name | 2 | 20250515 |
| 777d68c6-a5ab-e06c-d314-677b0b9af0c8 | Product name | 2 | 20240508 |
| 0306390c-dd77-4363-afe0-63c58088b2a1 | Product name | 1 | 20220120 |
| 503ea967-4b9c-48cf-9e87-c7975295849d | Product name | 2 | 20220120 |
| 190f2a5b-bbc8-65c7-fcb0-97891307b917 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 10237-783-12 | Orajel 3X Medicated For All Mouth Sores | 1 in 1 CARTON | GEL | 1 | 5 | |
| 10237-783-12 | Orajel 3X Medicated For All Mouth Sores | 3.5 g in 1 TUBE | GEL | 3.5 | 5 | |
| 10237-783-18 | Orajel 3X Medicated For All Mouth Sores | 1 in 1 CARTON | GEL | 1 | 5 | |
| 10237-783-18 | Orajel 3X Medicated For All Mouth Sores | 5.1 g in 1 TUBE | GEL | 5.1 | 5 | |
| 10237-783-42 | Orajel 3X Medicated For All Mouth Sores | 1 in 1 CARTON | GEL | 1 | 5 | |
| 10237-783-42 | Orajel 3X Medicated For All Mouth Sores | 11.9 g in 1 TUBE | GEL | 11.9 | 5 |
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 |
|---|---|---|---|---|---|---|
| Scope All Day CPC Antigingivitis/Antiplaque Mouthwash All Day | CETYLPYRIDINIUM CHLORIDE | The Procter & Gamble Manufacturing Company | d5f69341-b659-c74a-e053-2a95a90a317e | 2026-01-08 | Warnings | M022 |
| Crest Pro-Health Breath Purify and Gum Care | CETYLPYRIDINIUM CHLORIDE | The Procter & Gamble Manufacturing Company | d71ed31f-cc33-2fc3-e053-2995a90ad39b | 2026-01-08 | Warnings | M022 |
| Crest Pro-Health Clinical | CETYLPYRIDINIUM CHLORIDE | The Procter & Gamble Manufacturing Company | 0a295ee0-55c2-4f21-8f0a-70efc0e51694 | 2026-01-08 | Warnings | M022 |
| Crest Pro-Health Gum Care | CETYLPYRIDINIUM CHLORIDE | The Procter & Gamble Manufacturing Company | d721e2cb-8f67-3d07-e053-2995a90ae65a | 2026-01-08 | Warnings | M022 |
| Crest Pro-Health Advantage | CETYLPYRIDINIUM CHLORIDE | The Procter & Gamble Manufacturing Company | ddcd56fe-25d6-8195-e053-2a95a90a575a | 2026-01-08 | Warnings | M022 |
| Crest Pro-Health Bacteria Guard | CETYLPYRIDINIUM CHLORIDE | The Procter & Gamble Manufacturing Company | c2dc1f31-625d-a032-e053-2995a90a730d | 2026-01-08 | Warnings | M022 |
| Crest Pro Health Gum plus Bacteria Guard | CETYLPYRIDINIUM CHLORIDE | The Procter & Gamble Manufacturing Company | c598a4ab-5981-0068-e053-2a95a90af4fa | 2026-01-08 | Warnings | M022 |
| Oral B Gum Detoxify Special Care Rinse | CETYLPYRIDINIUM CHLORIDE | The Procter & Gamble Manufacturing Company | c2dcdde4-5542-1f87-e053-2995a90a261c | 2026-01-08 | Warnings | M022 |
| Crest Pro-Health Intense Fresh Mint | CETYLPYRIDINIUM CHLORIDE | The Procter & Gamble Manufacturing Company | 62991165-ec81-48a8-e053-2991aa0a54f3 | 2026-01-08 | Warnings | M022 |
| Crest Gum Care | CETYLPYRIDINIUM CHLORIDE | The Procter & Gamble Manufacturing Company | 72f1a02f-1d02-7e83-e053-2a91aa0a7947 | 2026-01-08 | Warnings | M022 |
| Crest Pro-Health Intense Clean Mint | CETYLPYRIDINIUM CHLORIDE | The Procter & Gamble Manufacturing Company | 6287bc3e-8b05-45d3-e053-2991aa0aaa10 | 2026-01-08 | Warnings | M022 |
| Crest Pro-Health Multi-Protection Refreshing Clean Mint | CETYLPYRIDINIUM CHLORIDE | The Procter & Gamble Manufacturing Company | 8867d791-7e93-4f39-aaaf-bfbee8296fd9 | 2026-01-08 | Warnings | M022 |
| 4x Medicated Toothache and Gum Cream | BENZOCAINE | HEB | a71c5259-cbcf-7566-e053-2995a90a2cb6 | 2026-01-08 | Warnings | M022 |
| Topco Associates LLC Maximum Strength | FLUORIDE | Topco Associates LLC | 387d264c-90cc-5e67-e063-6394a90a713d | 2026-01-08 | Warnings | M022 |
| TopCare Sensitive Extra Whitening | POTASSIUM NITRATE, SODIUM FLUORIDE | TOPCO Assoc. LLC | 835f41cf-e920-7df7-e053-2a91aa0a4479 | 2026-01-08 | Warnings | M022 |
| Scope Icy Blast | CETYLPYRIDINIUM CHLORIDE | The Procter & Gamble Manufacturing Company | 164ed151-01d3-021a-e063-6294a90a0e51 | 2026-01-08 | Warnings | M022 |
| Crest Pro-Health Advanced Enamel Care | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 1660e7d7-5b8d-8aba-e063-6294a90a50d8 | 2026-01-08 | Warnings | M022 |
| Crest Deep Cleanse Germ Treatment | CETYLPYRIDINIUM CHLORIDE | The Procter & Gamble Manufacturing Company | 2d6b15d4-7827-ec2f-e063-6294a90a82c8 | 2026-01-08 | Warnings | M022 |
| Crest Scope Original | CETYLPYRIDINIUM CHLORIDE | The Procter & Gamble Manufacturing Company | 21eed451-9368-146c-e063-6294a90af62b | 2026-01-08 | Warnings | M022 |
| 3x Medicated Mouth Sore Gel | BENZOCAINE | HEB | a71c5259-cbd1-7566-e053-2995a90a2cb6 | 2026-01-08 | Warnings | M022 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2266762 | benzocaine 20 % / menthol 0.1 % / zinc chloride 0.15 % Oral Gel | PSN | 99b589ac-9833-fb60-e053-2995a90a0935 | 5 |
| 2266762 | benzocaine 0.2 MG/MG / menthol 0.001 MG/MG / zinc chloride 0.0015 MG/MG Oral Gel | SCD | 99b589ac-9833-fb60-e053-2995a90a0935 | 5 |
| 2266762 | benzocaine 20 % / menthol 0.1 % / zinc chloride 0.15 % Oral Gel | SY | 99b589ac-9833-fb60-e053-2995a90a0935 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 10237-783-12 | 10237078312 | 1 TUBE in 1 CARTON (10237-783-12) / 3.5 g in 1 TUBE | 1 tube | 2019-11-01 | 0000-00-00 | No | No | Current |
| 10237-783-18 | 10237078318 | 1 TUBE in 1 CARTON (10237-783-18) / 5.1 g in 1 TUBE | 1 tube | 2019-11-01 | 0000-00-00 | No | No | Current |
| 10237-783-42 | 10237078342 | 1 TUBE in 1 CARTON (10237-783-42) / 11.9 g in 1 TUBE | 1 tube | 2019-11-01 | 0000-00-00 | No | No | Current |