Over-the-counter drug · OTC MONOGRAPH DRUG
Tecnu Calagel (Diphenhydramine hydrochloride) NDC 51879-802
Diphenhydramine hydrochloride 20 mg/g · Gel · Topical · Tec Laboratories Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51879-802-44 | 5187908024451879080244 | 144 PACKET in 1 CARTON (51879-802-44) / 1.86 g in 1 PACKET (51879-802-16)Marketed from Jul 23, 2019 | |
| 51879-802-66 | 5187908026651879080266 | 178.9 g in 1 BOTTLE (51879-802-66)Marketed from Jun 20, 2019 |
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)
- Tecnu Calagel
- Generic name (nonproprietary)
- diphenhydramine hydrochloride
- Active ingredients
- Diphenhydramine hydrochloride — 20 mg/g
- Dosage form
- Gel
- Route
- Topical
- Labeler
- Tec Laboratories Inc.NDC labeler code 51879
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 017
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 51879-802_4fece5ab-b042-c2ec-e063-6294a90affffSPL ID 4fece5ab-b042-c2ec-e063-6294a90affffSPL set ID 8bc9cbfe-1dd4-18ed-e053-2a95a90a7966RxCUI 1049880, 2174801UNII TC2D6JAD40
- Pharmacologic class
- Histamine-1 Receptor Antagonist
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
N451879080244followed by a unit qualifier and the quantityPackage 51879-0802-44. 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 pain and itching associated with: •minor burns •sunburn •minor cuts •scrapes •insect bites •minor skin irritations rashes due to: •poison oak •poison ivy •poison sumac
Excerpt only. Read the full label for complete information.
About NDC 51879-802
- What is NDC 51879-802?
- 51879-802 is the product NDC for Tecnu Calagel (diphenhydramine hydrochloride), Diphenhydramine hydrochloride 20 mg/g gel, listed with the FDA by Tec Laboratories Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Tecnu Calagel (Diphenhydramine Hydrochloride).
- What is the active ingredient?
- Diphenhydramine hydrochloride.
- Who is the labeler?
- Tec Laboratories Inc., NDC labeler code 51879. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Tecnu Calagel?
- 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 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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