Orasep
- Product NDC
- 54859-504
- 11-digit product format
- 548590504
- Labeler code
- 54859
- Product ID
- 54859-504_47461540-c155-bc33-e063-6394a90aaa9c
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Benzocaine, Menthol, Cetylpyridinium Chloride
- Dosage form
- LIQUID
- Route
- TOPICAL
- Labeler
- Llorens Pharmaceutical International Division
- Application
- M022
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2010-04-01
- Substance
- BENZOCAINE; CETYLPYRIDINIUM CHLORIDE; MENTHOL
- Active strength
- 2; .1; .5 mg/100mL; mg/100mL; mg/100mL
- Pharmacologic classes
- Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 54859-504 | I | Inactivated by FDA | 2026-08-17 | ||
| excluded package | package | 54859-504 | 54859-504-01 | I | Inactivated by FDA | 2026-08-17 |
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 | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded product | product | e2bbac7714bc… | 27bdfed8d636… | |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded package | package | 54859-504-01 | e2bbac7714bc… | 27bdfed8d636… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded product | product | 9bebd1f3094a… | 5416666fcb17… | |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded package | package | 54859-504-01 | 9bebd1f3094a… | 5416666fcb17… |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 54859-504-01 | 2020-12-23 | C162847 | 48780-1 | 9d75b9d1-01e9-f424-e053-dadaa90a57ce | Llorens- Orasep Spray 504 |
| 54859-504-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-01e9-f424-e053-dadaa90a57ce | Llorens- Orasep Spray 504 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 54859-504-01 | Orasep | 30 mL in 1 BOTTLE, SPRAY | LIQUID | 30 | 7 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 54859-504-01 | ML - Milliliter | 54859-504 | e2edd111-a748-40aa-aee8-d56f0533277d | 1 | 2012-07-24 |
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 |
|---|---|---|---|---|---|---|
| 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 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1426687 | benzocaine 2 % / cetylpyridinium chloride 0.1 % / menthol 0.5 % Mucosal Spray | PSN | 7c50d986-6a7b-425f-90a0-a60e21283bdf | 7 |
| 1485227 | Orasep 2 % / 0.5 % / 0.1 % Mucosal Spray, Reformulated Dec 2013 | PSN | 7c50d986-6a7b-425f-90a0-a60e21283bdf | 7 |
| 1485227 | benzocaine 20 MG/ML / cetylpyridinium chloride 1 MG/ML / menthol 5 MG/ML Mucosal Spray [Orasep Reformulated Dec 2013] | SBD | 7c50d986-6a7b-425f-90a0-a60e21283bdf | 7 |
| 1426687 | benzocaine 20 MG/ML / cetylpyridinium chloride 1 MG/ML / menthol 5 MG/ML Mucosal Spray | SCD | 7c50d986-6a7b-425f-90a0-a60e21283bdf | 7 |
| 1426687 | benzocaine 2 % / cetylpyridinium chloride 0.1 % / menthol 0.5 % Mucosal Spray | SY | 7c50d986-6a7b-425f-90a0-a60e21283bdf | 7 |
| 1485227 | Orasep (benzocaine 2 % / menthol 0.5 % / cetylpyridinium chloride 0.1 % ) Mucosal Spray, Reformulated Dec 2013 | SY | 7c50d986-6a7b-425f-90a0-a60e21283bdf | 7 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 54859-504-01 | 54859050401 | 30 mL in 1 BOTTLE, SPRAY (54859-504-01) | 30 ml | 2010-04-01 | 0000-00-00 | No | No | Current |