NDC 51879-802

Tecnu Calagel

Diphenhydramine Hydrochloride

Tecnu Calagel is a Topical Gel in the Human Otc Drug category. It is labeled and distributed by Tec Laboratories Inc.. The primary component is Diphenhydramine Hydrochloride.

Product ID51879-802_8bc9cbfe-1dd5-18ed-e053-2a95a90a7966
NDC51879-802
Product TypeHuman Otc Drug
Proprietary NameTecnu Calagel
Generic NameDiphenhydramine Hydrochloride
Dosage FormGel
Route of AdministrationTOPICAL
Marketing Start Date2019-06-20
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart348
Labeler NameTec Laboratories Inc.
Substance NameDIPHENHYDRAMINE HYDROCHLORIDE
Active Ingredient Strength20 mg/g
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 51879-802-06

1 BOTTLE in 1 CARTON (51879-802-06) > 178.9 g in 1 BOTTLE (51879-802-66)
Marketing Start Date2019-06-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 51879-802-44 [51879080244]

Tecnu Calagel GEL
Marketing CategoryOTC monograph not final
Application Numberpart348
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-07-23

NDC 51879-802-06 [51879080206]

Tecnu Calagel GEL
Marketing CategoryOTC monograph not final
Application Numberpart348
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-06-20

NDC 51879-802-16 [51879080216]

Tecnu Calagel GEL
Marketing CategoryOTC monograph not final
Application Numberpart348
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-07-23

NDC 51879-802-66 [51879080266]

Tecnu Calagel GEL
Marketing CategoryOTC monograph not final
Application Numberpart348
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-06-20

Drug Details

OpenFDA Data

SPL SET ID:8bc9cbfe-1dd4-18ed-e053-2a95a90a7966
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 2174801
  • 1049880
    • UPC Code
  • 0083926860019

    • NDC Crossover Matching brand name "Tecnu Calagel" or generic name "Diphenhydramine Hydrochloride"

    NDCBrand NameGeneric Name
    51879-802Tecnu CalagelTecnu Calagel
    0363-7100Adult Allergy ReliefDiphenhydramine Hydrochloride
    0363-0100ALLERGY RELIEFDIPHENHYDRAMINE HYDROCHLORIDE
    0113-7479basic care allergy reliefDiphenhydramine Hydrochloride
    0363-0710childrens Allergy Dye Free Wal DrylDiphenhydramine hydrochloride
    0363-0004Childrens WAL-DRYLDiphenhydramine Hydrochloride
    0121-0865Diphenhydramine HCl Oral Solutiondiphenhydramine hydrochloride
    0121-1730Diphenhydramine HCl Oral Solutiondiphenhydramine hydrochloride
    0121-0489DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDE
    0121-0978DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDE
    0185-0648diphenhydramine hydrochloridediphenhydramine hydrochloride
    0185-0649diphenhydramine hydrochloridediphenhydramine hydrochloride
    0363-0293Dye Free Wal Dryl AllergyDiphenhydramine Hydrochloride
    0363-0753Dye Free Wal Sleep ZDIPHENHYDRAMINE HYDROCHLORIDE
    0113-0462Good Sense Allergy Reliefdiphenhydramine hydrochloride
    0113-0479good sense allergy reliefDiphenhydramine Hydrochloride
    0113-0431good sense nighttime sleep aidDiphenhydramine Hydrochloride
    0113-1909good sense sleep aiddiphenhydramine hydrochloride
    0363-0092Wal DrylDiphenhydramine Hydrochloride
    0363-0379wal dryl allergyDiphenhydramine Hydrochloride
    0363-0060Wal-Sleep ZDiphenhydramine Hydrochloride
    0363-0223Wal-SomDiphenhydramine hydrochloride
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