Over-the-counter drug · OTC MONOGRAPH DRUG
Tina Davies IceCream NDC 84313-001
lidocaine hydrochloride, phenylephrine hydrochloride · Lidocaine hydrochloride 5 g/100mL; Phenylephrine hydrochloride .25 g/100mL · Cream · Topical · TINA DAVIES PROFESSIONAL LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 84313-001-05 | 84313000105 | 5 mL in 1 TUBE (84313-001-05)Marketed from Jun 12, 2024 · Sample package | |
| 84313-001-15 | 84313000115 | 1 TUBE in 1 CARTON (84313-001-15) / 15 mL in 1 TUBEMarketed from Mar 20, 2026 | |
| 84313-001-30 | 84313000130 | 1 TUBE in 1 CARTON (84313-001-30) / 30 mL in 1 TUBEMarketed from Jun 12, 2024 |
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)
- Tina Davies IceCream
- Generic name (nonproprietary)
- lidocaine hydrochloride, phenylephrine hydrochloride
- Active ingredients
- Lidocaine hydrochloride — 5 g/100mLPhenylephrine hydrochloride — .25 g/100mL
- Dosage form
- Cream
- Route
- Topical
- Labeler
- TINA DAVIES PROFESSIONAL LLCNDC labeler code 84313
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 015
- Marketing start
- Marketing end
- Other FDA classes
- Adrenergic alpha1-Agonists (Mechanism)Amides (Chemical structure)Local Anesthesia (Physiologic effect)
- Identifiers
- Product ID 84313-001_5282563a-c4f4-48d2-90ca-aac5fa7318ecSPL ID 5282563a-c4f4-48d2-90ca-aac5fa7318ecSPL set ID 6a2b3199-f405-4455-9a02-8885d24eef9cRxCUI 2684985UNII V13007Z41A, 04JA59TNSJUPC 0846667003011
- 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 HCPCS code in Med-Code's directory. Topical products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N484313000105followed by a unit qualifier and the quantityPackage 84313-0001-05. 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 the temporary relief of anorectal itching and discomfort associated with hemorrhoids. • For temporary relief of pain.
Excerpt only. Read the full label for complete information.
About NDC 84313-001
- What is NDC 84313-001?
- 84313-001 is the product NDC for Tina Davies IceCream, Lidocaine hydrochloride 5 g/100mL; Phenylephrine hydrochloride .25 g/100mL cream, listed with the FDA by TINA DAVIES PROFESSIONAL LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Tina Davies IceCream (Lidocaine Hydrochloride, Phenylephrine Hydrochloride).
- What is the active ingredient?
- Lidocaine hydrochloride, Phenylephrine hydrochloride.
- Who is the labeler?
- TINA DAVIES PROFESSIONAL LLC, NDC labeler code 84313. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Tina Davies IceCream?
- 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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