Over-the-counter drug · OTC MONOGRAPH DRUG
Pain Relief (Benzocaine) NDC 61010-8100
Benzocaine 200 mg/g · Liquid · Topical · Safetec of America, Inc.
NDC codes
FDA NDC DirectoryProduct NDC (as listed)61010-8100Labeler and product segments. Claims need a package NDC.
Product NDC at billing width61010-8100Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 61010-8100-1 | 6101081000161010810001 | 144 PACKET in 1 BOX (61010-8100-1) / .75 g in 1 PACKETMarketed from Feb 1, 2019 | |
| 61010-8100-2 | 6101081000261010810002 | .5 g in 1 PACKET (61010-8100-2)Marketed from Feb 1, 2019 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Pain Relief
- Generic name (nonproprietary)
- benzocaine
- Active ingredients
- Benzocaine — 200 mg/g
- Dosage form
- Liquid
- Route
- Topical
- Labeler
- Safetec of America, Inc.NDC labeler code 61010
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 017
- Marketing start
- Listing expires
- Other FDA classes
- Allergens (Chemical structure)Cell-mediated Immunity (Physiologic effect)Increased Histamine Release (Physiologic effect)
- Identifiers
- Product ID 61010-8100_11867852-2084-bc57-e063-6394a90a45daSPL ID 11867852-2084-bc57-e063-6394a90a45daSPL set ID de84e598-d047-4fae-b2ed-155a3788bc6fRxCUI 248280UNII U3RSY48JW5
- Pharmacologic class
- Standardized Chemical Allergen
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
N461010810001followed by a unit qualifier and the quantityPackage 61010-8100-01. 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 temporarily relieves pain caused by toothache dental work minor irritation or injury of the mouth and gums canker sores gum sores cheek bites denture irritation
Excerpt only. Read the full label for complete information.
About NDC 61010-8100
- What is NDC 61010-8100?
- 61010-8100 is the product NDC for Pain Relief (benzocaine), Benzocaine 200 mg/g liquid, listed with the FDA by Safetec of America, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Pain Relief (Benzocaine).
- What is the active ingredient?
- Benzocaine.
- Who is the labeler?
- Safetec of America, Inc., NDC labeler code 61010. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Pain Relief?
- 62 other product NDCs are listed under this name. See all Pain Relief NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Pain Relief products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Pain Reliefacetaminophen | Acetaminophen 325 mg/1 | TabletOral | Shield Pharmaceuticals Corp. | 83059-0160 | — |
| Pain Reliefmenthol spray | Menthol 76.6 mg/mL | SprayTopical | Owell Naturals Brand, LLC | 83570-003 | 83570-0003-02 |
| Pain Reliefarnica montana, belladonna, gelsemium sempervirens, gnaphalium polycephalum, magnesia phosphorica, sanguinaria canadensis, salix alba | Arnica montana whole 6 [hp_X]/1 + 6 more ingredients | TabletOral | NaturalCare | 70163-0022 | 70163-0022-01 |
| pain reliefacetaminophen | Acetaminophen 500 mg/1 | Tablet, Film coatedOral | HyVee Inc | 42507-813 | 42507-0813-78 |
| Pain Reliefmenthol | Menthol 10.5 g/100mL | SprayTopical | Trifecta Pharmaceuticals USA, LLC. | 69396-175 | 69396-0175-03 |
| Pain Reliefacetaminophen | Acetaminophen 500 mg/1 | TabletOral | HYVEE INC | 42507-103 | 42507-0103-04 |
| Pain Reliefacetaminophen | Acetaminophen 650 mg/1 | Tablet, Extended releaseOral | HYVEE INC | 42507-303 | 42507-0303-03 |
| Pain Reliefacetaminophen | Acetaminophen 500 mg/1 | Tablet, CoatedOral | HYVEE INC | 42507-404 | 42507-0404-09 |
| Pain Reliefacetaminophen | Acetaminophen 500 mg/1 | Tablet, CoatedOral | HYVEE INC | 42507-592 | 42507-0592-03 |
| Pain Relieflidocaine | Lidocaine .04 g/g | PatchTopical | Shanghai Chuangshi Medical Technology (Group) Co., Ltd. | 73557-189 | 73557-0189-30 |
Other NDCs under M 017
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 |
|---|---|---|---|---|
| Extra Strength Itch Reliefdiphenhydramine hcl and zinc acetate | Diphenhydramine hydrochloride 20 mg/g; Zinc acetate 1 mg/g | SprayTopical | Meijer Distribution Inc | 79481-0598 |
| 3X Medicated Toothache and Gum Gelbenzocaine | Benzocaine 20 g/100g + 2 more ingredients | GelOral | Rite Aid | 11822-0613 |
| Meijer Pain Relieving Balm Analgesictrolamine salicylate | Trolamine salicylate 10 mg/g | CreamTopical | Meijer Distribution, Inc | 41250-356 |
| Ralli Rapid Pain Relief Roll onmenthol | Menthol 100 mg/mL | GelTopical | Troy Manufacturing, Inc. | 63936-9527 |
| CVS Health Pain Relievingcamphor (synthetic), menthol (unspecified form), methyl salicylate | Camphor (Synthetic) 28 mg/1 + 2 more ingredients | PatchTransdermal | Natural Essentials, Inc. | 66902-280 |
| Pbz Otctripelennamine hcl 1% | Tripelennamine 1 g/100g | CreamTopical | Kingsway Pharmaceuticals dba NFI, LLC | 69993-151 |
| Hydrocortisone | Hydrocortisone 1 g/100g | CreamTopical | Henry Schein | 0404-0166 |
| American Safety and First Aidhydrocortisone acetate | Hydrocortisone acetate 10 mg/g | CreamTopical | Orazen Inc | 71927-015 |
| MyDerm Bite Reliefbenzocaine | Benzocaine 5 g/100g | OintmentTopical | Inspec Solutions LLC. | 72667-019 |
| Thera Plus Maximum Strength Hydrocortisonehydrocortisone | Hydrocortisone 10 mg/g | CreamTopical | Fourstar Group USA, Inc | 80684-197 |
| Lidocaine 4% | Lidocaine 400 mg/10g | PatchTransdermal | Marcella Health | 85096-201 |
| Tough Love Pain Relievinglidocaine hcl | Lidocaine 4 g/100g | CreamTopical | Allure Labs | 62742-4222 |
| Stopain Extra Strength Gelmenthol | Menthol 80 mg/mL | GelTopical | Troy Manufacturing, Inc. | 63936-9506 |
| Fast Freeze Lidocaine Roll-Onlidocaine hydrochloride, benzyl alcohol | Lidocaine hydrochloride 40 mg/mL; Benzyl alcohol 10 mg/mL | LiquidTopical | Natural Essentials, Inc. | 66902-235 |
| Walgreens pain relievinglidocaine 4% | Lidocaine 4 g/100g | Aerosol, SprayTopical | Walgreens | 0363-3038 |
| Bikini Zone Medicated Cremelidocaine | Lidocaine 2 g/100g | CreamTopical | Kingsway Pharmaceuticals dba NFI, LLC | 69993-043 |
| American Safety First Aidlidocaine hcl | Lidocaine hydrochloride 20 mg/mL | SprayTopical | Orazen Inc | 71927-012 |
| ACOLYE Lidocaine Cream Topical Analgesia Creamlidocaine,menthol | Lidocaine 4 g/100g; Menthol 1 g/100g | CreamTopical | Guangdong Aimu Biological Technology Co., Ltd | 83566-617 |
| Healmusz Eczemahydrocortisone 1% eczema | Hydrocortisone 1 g/100g | CreamTopical | Jiangxi Yudexi Pharmaceutical Co., LTD | 85248-203 |
| ELAIMEI Numbing Creamlidocaine 4% | Lidocaine 4 g/100mL | CreamTopical | Shenzhen Shandian Jingling Technology Co., Ltd. | 83804-005 |
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