Giltuss Bucalsep
- Product NDC
- 65852-015
- 11-digit product format
- 658520015
- Labeler code
- 65852
- Product ID
- 65852-015_3fa233dc-156d-1e95-e063-6294a90a8bbd
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Benzocaine, Menthol, Zinc chloride
- Dosage form
- SPRAY
- Route
- ORAL; TOPICAL
- Labeler
- Dextrum Laboratories Inc.
- Application
- M022
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2018-07-26
- Substance
- BENZOCAINE; MENTHOL; ZINC CATION
- Active strength
- 6.5; .1; .12 mg/100mL; mg/100mL; mg/100mL
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Giltuss Bucalsep
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ZINC CATION | 6.5 mg/100mL |
| BENZOCAINE | .1 mg/100mL |
| MENTHOL | .12 mg/100mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 13S1S8SF37 | Internal UNII lookup |
| U3RSY48JW5 | Internal UNII lookup |
| L7T10EIP3A | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 3fa233dc-156c-1e95-e063-6294a90a8bbd | 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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 65852-015-01 | Giltuss Bucalsep | 1 in 1 CARTON | SPRAY | 1 | 1 | |
| 65852-015-01 | Giltuss Bucalsep | 30 mL in 1 BOTTLE, PLASTIC | SPRAY | 30 | 1 |
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 |
|---|---|---|---|---|---|---|
| Hydrogen Peroxide 3 Percent | HYDROGEN PEROXIDE | Harris Teeter, LLC | 7e5f175d-f0d6-4665-ac14-1873d6b99c80 | 2026-08-12 | Warnings | M022 |
| Antiseptic | EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL | WALMART INC. (see also Equate) | 584b38ce-d1ef-4ecc-a887-7c96e7f9669f | 2026-08-12 | Warnings | M022 |
| Gingicaine Gel Variety Pak | GINGICAINE GEL VARIETY PAK | Gingi-Pak a Division of the Belport | 62ed4ff3-18f6-5c67-e053-2991aa0a7792 | 2026-08-11 | Warnings | M022 |
| Hydrogen Peroxide 3 Percent ReadyInCase | HYDROGEN PEROXIDE | P & L Development, LLC | b0866db5-3b0d-4478-9b3b-1f077d2f5393 | 2026-08-06 | Warnings | M022 |
| Ollie Fresh Mint | SODIUM FLUORIDE, POTASSIUM NITRATE | Brio Product Group LLC. | ebeec44f-3c22-43f2-9256-6ece6025c105 | 2026-08-06 | Warnings | M022 |
| Tumeez Organic Apple | CALCIUM CARBONATE | BFY LLC | f561685a-5260-59c6-e053-2a95a90ae206 | 2026-08-06 | Warnings | M022 |
| Candee Caine Topical Anesthetic | BENZOCAINE | Top Quality Manufacturing, Inc. | 5868c5a1-273f-f023-e063-6394a90ac9d8 | 2026-08-06 | Warnings | M022 |
| Candee Caine Topical Anesthetic | BENZOCAINE | Top Quality Manufacturing, Inc. | 58690bb5-9604-26a4-e063-6394a90afdbe | 2026-08-06 | Warnings | M022 |
| Candee Caine Topical Anesthetic | BENZOCAINE | Top Quality Manufacturing, Inc. | 586918cf-7b13-5999-e063-6294a90a88a9 | 2026-08-06 | Warnings | M022 |
| Candee Caine Topical Anesthetic | BENZOCAINE | Top Quality Manufacturing, Inc. | 586924a0-322d-5dc3-e063-6294a90a1556 | 2026-08-06 | Warnings | M022 |
| Candee Caine Topical Anesthetic | BENZOCAINE | Top Quality Manufacturing, Inc. | 58692e90-de74-52d3-e063-6394a90a9702 | 2026-08-06 | Warnings | M022 |
| Candee Caine Topical Anesthetic | BENZOCAINE | Top Quality Manufacturing, Inc. | 586937ae-46af-7066-e063-6294a90ae53e | 2026-08-06 | Warnings | M022 |
| Freshness Blueberry Toothpaste100g | FRESHNESS BLUEBERRY TOOTHPASTE 100G | WORLD DENTISTS ASSOCIATION AMERICA LIMITED | 586d1dba-87fc-b676-e063-6294a90a1470 | 2026-08-06 | Warnings | M022 |
| Freshness Coffee Toothpaste100g | FRESHNESS COFFEE TOOTHPASTE 100G | WORLD DENTISTS ASSOCIATION AMERICA LIMITED | 586d79e9-2f0f-fa72-e063-6394a90a8dea | 2026-08-06 | Warnings | M022 |
| Freshness Flower Rose Toothpaste100g | FRESHNESS FLOWER ROSE TOOTHPASTE 100G | WORLD DENTISTS ASSOCIATION AMERICA LIMITED | 586d7f5e-55e0-4fd2-e063-6294a90a92b6 | 2026-08-06 | Warnings | M022 |
| 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 |
| Made by Dentists Enamel 10 Fluoride Anticavity | POTASSIUM NITRATE, SODIUM FLUORIDE | Made By Dentists Inc | 3c62eab1-0cb6-4bdf-bfd4-c5afe734d036 | 2026-07-24 | 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 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 65852-015-01 | 65852001501 | 1 BOTTLE, PLASTIC in 1 CARTON (65852-015-01) / 30 mL in 1 BOTTLE, PLASTIC | 2018-07-26 | No | No | Current |