Over-the-counter drug · OTC MONOGRAPH DRUG
Zensa Numbing Gel NDC 69805-400
lidocaine 5%, phenylephrine hydrochloride 0.25% · Phenylephrine hydrochloride .25 g/100g; Lidocaine 5 g/100g · Gel · Rectal · Alera Skin Care Products Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69805-400-01 | 6980504000169805040001 | 1 TUBE in 1 CARTON (69805-400-01) / 30 g in 1 TUBEMarketed from Sep 25, 2023 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Zensa Numbing Gel
- Generic name (nonproprietary)
- lidocaine 5%, phenylephrine hydrochloride 0.25%
- Active ingredients
- Phenylephrine hydrochloride — .25 g/100gLidocaine — 5 g/100g
- Dosage form
- Gel
- Route
- Rectal
- Labeler
- Alera Skin Care Products Inc.NDC labeler code 69805
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 015
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha1-Agonists (Mechanism)Amides (Chemical structure)Local Anesthesia (Physiologic effect)
- Identifiers
- Product ID 69805-400_065a6eec-3897-0da8-e063-6394a90a849dSPL ID 065a6eec-3897-0da8-e063-6394a90a849dSPL set ID 065a6eec-3896-0da8-e063-6394a90a849dRxCUI 2621576UNII 04JA59TNSJ, 98PI200987UPC 0628235620154
- Pharmacologic class
- Amide Local Anesthetic; Antiarrhythmic; alpha-1 Adrenergic Agonist
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N469805040001followed by a unit qualifier and the quantityPackage 69805-0400-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
USES For temporary relief of local discomfort associated with anorectal disorders. For temporary relief of pain, soreness and burning. Temporarily shrinks hemorrhoidal tissue.
Excerpt only. Read the full label for complete information.
About NDC 69805-400
- What is NDC 69805-400?
- 69805-400 is the product NDC for Zensa Numbing Gel, Phenylephrine hydrochloride .25 g/100g; Lidocaine 5 g/100g gel, listed with the FDA by Alera Skin Care Products Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Zensa Numbing Gel (Lidocaine 5%, Phenylephrine Hydrochloride 0.25%).
- What is the active ingredient?
- Phenylephrine hydrochloride, Lidocaine.
- Who is the labeler?
- Alera Skin Care Products Inc., NDC labeler code 69805. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Zensa Numbing Gel?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under M 015
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| 0.25 % PHENYLEPHRINE HCl HEMORRHOIDALmineral oil, petrolatum, phenylephrine hydrochloride | Mineral oil 14 g/100g + 2 more ingredients | OintmentTopical | Nantong Health & Beyond Hygienic Products Inc. | 43473-094 |
| 0.25 % PHENYLEPHRINE HCl HEMORRHOIDALmineral oil, petrolatum, phenylephrine hydrochloride | Mineral oil 14 g/100g + 2 more ingredients | OintmentTopical | Universal Distribution Center LLC | 52000-438 |
| 5% Lidocaine 10g5% lidocaine | Lidocaine 5 g/100g | CreamTopical | Chongqing Mandongzi Technology Co., Ltd | 88002-001 |
| Acolye Numbing Cream Anorectal(Hemorrhoidal) Creamlidocaine | Lidocaine 5 g/100g | CreamTopical | Guangzhou Haishi Biological Technology Co., Ltd. | 60771-0028 |
| Acolye Numbing Cream Anorectal(Hemorrhoidal) Creamlidocaine | Lidocaine 5 g/100g | CreamTopical | Guangzhou Haishi Biological Technology Co., Ltd. | 60771-0029 |
| Acolye Numbing Cream Anorectal(Hemorrhoidal) Creamlidocaine | Lidocaine 5 g/100g | CreamTopical | Guangdong Aimu Biological Technology Co., Ltd | 83566-615 |
| Adellina Lidocaine Numbing Cream Anorectal(Hemorrhoidal) Creamlidocaine | Lidocaine 5 g/100g | CreamTopical | Guangzhou Haishi Biological Technology Co., Ltd. | 60771-0041 |
| Adellina Lidocaine Numbing Cream Topical Anorectal Creamlidocaine | Lidocaine 5 g/100g | CreamTopical | Guangdong Aimu Biological Technology Co., Ltd | 83566-612 |
| Adellina Lidocaine Numbing Cream Topical Anorectal Creamlidocaine | Lidocaine 5 g/100g | CreamTopical | Guangdong Aimu Biological Technology Co., Ltd | 83566-614 |
| ADVANCED NUMB Topical Anestheticlidocaine hydrochloride | Lidocaine hydrochloride 50 mg/g | CreamTopical | Uber Scientific, LLC | 71131-052 |
| AER Pre-moistened Witch Hazel Padwitch hazel | Witch hazel 500 mg/mL | SolutionRectal, Topical | Birchwood Laboratories LLC | 50289-3250 |
| AER Traveler Toweletteaer traveler | Witch hazel .5 g/1 | SolutionRectal, Topical | Birchwood Laboratories LLC | 50289-4200 |
| Americainebenzocaine | Benzocaine 5.6 g/28g | OintmentTopical | Insight Pharmaceuticals LLC | 63736-375 |
| AnievaLClidocaine | Lidocaine .05 g/g | CreamTopical | Blackstone Products, LLC | 87798-001 |
| ANIXIKE Numbinglidocaine4% numbing | Lidocaine 4 g/100g | CreamTopical | Jiangxi Yudexi Pharmaceutical Co., LTD | 85248-166 |
| Arlun LIDOCAINE Creamlidocaine cream | Lidocaine 5 g/100g | CreamTopical | Guangzhou Jingliang Cosmetics Co., Ltd. | 87408-021 |
| Assured Bikini Smooth Creamlidocaine | Lidocaine 2 g/100g | CreamTopical | Zhejiang Jingwei Pharmaceutical Co., Ltd. | 55621-011 |
| Asteroidmenthol, petrolatum, zinc oxide | Menthol .098 g/28g + 2 more ingredients | OintmentTopical | HEALTHTEX LIMITED | 84107-552 |
| B-SURE Traveler Toweletteb-sure traveler | Witch hazel .5 g/g | SolutionRectal, Topical | Birchwood Laboratories LLC | 50289-9250 |
| Barrier Protectant Creambarrier cream | Menthol 1 mg/g; Zinc oxide 200 mg/g | OintmentTopical | Cardinal Health | 63517-003 |
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