tecnu calagel

Generic: diphenhydramine hydrochloride

Labeler: tec laboratories inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name tecnu calagel
Generic Name diphenhydramine hydrochloride
Labeler tec laboratories inc.
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

diphenhydramine hydrochloride 20 mg/g

Manufacturer
Tec Laboratories Inc.

Identifiers & Regulatory

Product NDC 51879-802
Product ID 51879-802_415efa67-a4cb-04b3-e063-6394a90a3be9
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M017
Listing Expiration 2026-12-31
Marketing Start 2019-06-20

Pharmacologic Class

Classes
histamine h1 receptor antagonists [moa] histamine-1 receptor antagonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 51879802
Hyphenated Format 51879-802

Supplemental Identifiers

RxCUI
1049880 2174801
UPC
0083926860019
UNII
TC2D6JAD40

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name tecnu calagel (source: ndc)
Generic Name diphenhydramine hydrochloride (source: ndc)
Application Number M017 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/g
source: ndc
Packaging
  • 144 PACKET in 1 CARTON (51879-802-44) / 1.86 g in 1 PACKET (51879-802-16)
  • 178.9 g in 1 BOTTLE (51879-802-66)
source: ndc

Packages (2)

51879-802-44 144 PACKET in 1 CARTON (51879-802-44) / 1.86 g in 1 PACKET (51879-802-16) 51879-802-66 178.9 g in 1 BOTTLE (51879-802-66)

Ingredients (1)

diphenhydramine hydrochloride (20 mg/g)

Linked Drug Pages (1)

Tecnu Calagel ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "415efa67-a4cb-04b3-e063-6394a90a3be9", "openfda": {"upc": ["0083926860019"], "unii": ["TC2D6JAD40"], "rxcui": ["1049880", "2174801"], "spl_set_id": ["8bc9cbfe-1dd4-18ed-e053-2a95a90a7966"], "manufacturer_name": ["Tec Laboratories Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "144 PACKET in 1 CARTON (51879-802-44)  / 1.86 g in 1 PACKET (51879-802-16)", "package_ndc": "51879-802-44", "marketing_start_date": "20190723"}, {"sample": false, "description": "178.9 g in 1 BOTTLE (51879-802-66)", "package_ndc": "51879-802-66", "marketing_start_date": "20190620"}], "brand_name": "Tecnu Calagel", "product_id": "51879-802_415efa67-a4cb-04b3-e063-6394a90a3be9", "dosage_form": "GEL", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "51879-802", "generic_name": "Diphenhydramine Hydrochloride", "labeler_name": "Tec Laboratories Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Tecnu Calagel", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "20 mg/g"}], "application_number": "M017", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20190620", "listing_expiration_date": "20261231"}