Gumsol
- Product NDC
- 52083-714
- Requested package NDC
- 52083-714-01
- 11-digit product format
- 520830714
- Labeler code
- 52083
- Product ID
- 52083-714_df716e50-f0a6-4548-b354-29dd8c29924c
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Benzocaine, Zinc Chloride
- Dosage form
- SPRAY
- Route
- ORAL
- Labeler
- Kramer Novis
- Application
- M022
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2014-02-28
- Substance
- BENZOCAINE; ZINC CHLORIDE
- Active strength
- 1.5; .03 g/30mL; g/30mL
- 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
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|
| 2025-08-27 00:01 UTC · source 2025-08-26 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Gumsol
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| BENZOCAINE | 1.5 g/30mL |
| ZINC CHLORIDE | .03 g/30mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| U3RSY48JW5 | Internal UNII lookup |
| 86Q357L16B | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 485558 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 3bb651d9-d1c4-4c25-bcfc-cd13e2f0d3bf | 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 |
| 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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 52083-714-01 | 2025-11-18 | C162847 | 48780-1 | 2cef2736-9d02-d83d-e063-dadaa90ab31f | GUMSOL |
| 52083-714-01 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-9d02-d83d-e063-dadaa90ab31f | GUMSOL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 52083-714-01 | Gumsol | 30 mL in 1 BOTTLE | SPRAY | 30 | 3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 52083-714-01 | ML - Milliliter | 52083-714 | a3d40f00-3276-485a-b753-8b0f10a9ed8f | 1 | 2014-04-03 |
DailyMed Socrata Ingredients#
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 |
|---|---|---|---|---|---|---|
| PRO-SYS | ORAL WOUND CLEANSER | Forward Science Technologies LLC | c357c8f8-6fd6-c2f8-e053-2995a90a4023 | 2026-07-30 | Warnings | M022 |
| Lornamead Natural White | FLUORIDE | Lornamead Products | 9d7d08d7-8ca4-4b05-8b74-3bfa372b1608 | 2026-07-29 | Warnings | M022 |
| Saline | NASAL | BEST CHOICE (VALU MERCHANDISERS COMPANY) | 71485e82-bf54-4b8b-8dd2-2a0761534520 | 2026-07-17 | Warnings | M022 |
| Good Neighbor Sore Throat Cherry Flavor | PHENOL | AMERISOURCE BERGEN | aa8fb8ff-61c7-41ba-9a23-1052e2b6cd7f | 2026-07-13 | Warnings | M022 |
| ABC Sore Throat Menthol Flavor | PHENOL | AMERISOURCE BERGEN | 9d9baf58-4790-4ff4-a462-5eb70c0e80c5 | 2026-07-13 | Warnings | M022 |
| Hydrogen Peroxide | HYDROGEN PEROXIDE | P & L Development, LLC | 350b5f64-d152-40cb-b22f-98541f0e1b0a | 2026-07-09 | Warnings | M022 |
| Quality Choice Natural White | FLUORIDE | CHAIN DRUG MARKETING ASSOCIATION INC | 561a75c2-a40c-ba7c-e063-6294a90aa119 | 2026-07-08 | Warnings | M022 |
| SALINE NASAL | SODIUM CHLORIDE | ALAINA HEALTHCARE PRIVATE LIMITED | ed30a7f9-7132-42da-9bed-63a9b1c80ab2 | 2026-07-07 | Warnings | M022 |
| Tumeez Organic Apple | CALCIUM CARBONATE | BFY LLC | f561685a-5260-59c6-e053-2a95a90ae206 | 2026-07-06 | Warnings | M022 |
| MUCINEX INSTASOOTHE SORE THROAT PLUS PAIN RELIEF | HEXYLRESORCINOL | Reckitt Benckiser LLC | 4c150222-06ea-4fcf-967f-84e19846bd66 | 2026-07-03 | Warnings | M022 |
| Dental system starter kit | US CONVENIENCE KIT (718907) | Dyson Technology Limited | 5355b79b-711f-1a4a-e063-6394a90afc4b | 2026-06-30 | Warnings | M022 |
| Anticavity and sensitive peppermint | 907 US VARIANT ANTICAVITY AND SENSITIVE TOOTHPASTE NON FOAMING PEPPERMINT | Dyson Technology Limited | 5332ab71-d994-39cf-e063-6294a90a0d98 | 2026-06-30 | Warnings | M022 |
| NebuClear MD Saline | NEBUCLEAR MD SALINE | Blue Echo Care LLC | 55820ff9-7b4b-2bce-e063-6394a90a8b43 | 2026-06-30 | Warnings | M022 |
| NebuClear MD Saline | NEBUCLEAR MD SALINE | Blue Echo Care LLC | 55806cb8-cf92-c4e5-e063-6394a90aaa2d | 2026-06-30 | Warnings | M022 |
| NebuClear MD Saline | NEBUCLEAR MD SALINE | Blue Echo Care LLC | 5581d8e5-4105-e9da-e063-6394a90a316e | 2026-06-30 | Warnings | M022 |
| Corinz | CETYLPYRIDINIUM CHLORIDE | Sage Products, LLC | 685b6023-89c4-417e-af2d-52e831855da1 | 2026-06-29 | Warnings | M022 |
| Antiplaque solution | CETYLPYRIDINIUM CHLORIDE | Sage Products LLC | 881d4d08-4b45-486a-93af-18c0e00a5b0e | 2026-06-29 | Warnings | M022 |
| GingiCaine gel, Cherry | GINGICAINE GEL, CHERRY FLAVOR | Gingi-Pak a Division of the Belport | 6274d92e-c4e9-34fd-e053-2991aa0ae604 | 2026-06-29 | Warnings | M022 |
| GingiCaine Gel, Mint Julep | GINGICAINE GEL, MINT JULEP FLABVOR | Gingi-Pak a Division of the Belport | 6285fe10-08ba-8044-e053-2991aa0a8e8b | 2026-06-29 | Warnings | M022 |
| GingiCaine Gel, Pina Colada | GINGICAINE GEL, PINA COLADA FLAVOR | Gingi-Pak a Division of the Belport | 6284e1fe-be33-69bf-e053-2991aa0a90ab | 2026-06-29 | Warnings | M022 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 485558 | benzocaine 5 % / zinc chloride 0.1 % Mucosal Spray | PSN | 3bb651d9-d1c4-4c25-bcfc-cd13e2f0d3bf | 3 |
| 485558 | benzocaine 50 MG/ML / zinc chloride 1 MG/ML Mucosal Spray | SCD | 3bb651d9-d1c4-4c25-bcfc-cd13e2f0d3bf | 3 |
| 485558 | benzocaine 5 % / zinc chloride 0.1 % Mucosal Spray | SY | 3bb651d9-d1c4-4c25-bcfc-cd13e2f0d3bf | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 52083-714-01 | 52083071401 | 30 mL in 1 BOTTLE (52083-714-01) | 30 ml | 2014-02-28 | 0000-00-00 | No | No | Current |