Home NDC 51879-802 Tecnu Calagel
Product NDC 51879-802
11-digit product format 518790802
Labeler code 51879
Product ID 51879-802_4fece5ab-b042-c2ec-e063-6294a90affff
Type HUMAN OTC DRUG
Nonproprietary name Diphenhydramine Hydrochloride
Dosage form GEL
Route TOPICAL
Labeler Tec Laboratories Inc.
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-06-20
Substance DIPHENHYDRAMINE HYDROCHLORIDE
Active strength 20 mg/g
Pharmacologic classes Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 51879-802 51879-802-06 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Tecnu Calagel
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIPHENHYDRAMINE HYDROCHLORIDE 20 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination TC2D6JAD40 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1049880 Internal RxNorm lookup 2174801 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 51879-802-06 Tecnu Calagel 1 in 1 CARTON GEL 1 8 51879-802-16 Tecnu Calagel 1.86 g in 1 PACKET GEL 1.86 8 51879-802-44 Tecnu Calagel 144 in 1 CARTON GEL 144 8 51879-802-66 Tecnu Calagel 178.9 g in 1 BOTTLE GEL 178.9 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51879-802 TECNU CALAGEL (DIPHENHYDRAMINE HYDROCHLORIDE) GEL [TEC LABORATORIES INC.] 6 Current NDC, Legacy NDC, 4 package rows 20241107_8bc9cbfe-1dd4-18ed-e053-2a95a90a7966.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 117 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Walgreens Flexible Pain Relieving Lidocaine LIDOCAINE, MENTHOL Walgreen Co. 6f070fa3-a61a-4523-a470-ab58bf9400a3 2024-11-27 Warnings Exact identifier application number: M017 Benadryl Original Strength Itch Stopping DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE Kenvue Brands LLC 920c50cb-9bdd-4a36-bb3d-c2559db73327 2024-11-26 Warnings Exact identifier application number: M017 Universal ARTHRITIS and SPORT METHYL SALICYLATE, CAPSICUM Universal Distribution Center LLC 884907a8-c884-4cce-ac10-9d4848fdba3e 2024-11-22 Warnings Exact identifier application number: M017 Universal ARTHRITIS and SPORT METHYL SALICYLATE, CAPSICUM Universal Distribution Center LLC 7f067e95-e01c-4b9a-a02e-0af097beb18c 2024-11-22 Warnings Exact identifier application number: M017 Universal ARTHRITIS and SPORT METHYL SALICYLATE, CAPSICUM Universal Distribution Center LLC 9ece9b3a-0092-4c1c-a913-c2fefcd70541 2024-11-22 Warnings Exact identifier application number: M017 Sting Relief Pad BENZOCAINE, ISOPROPYL ALCOHOL Changzhou Maokang Medical Products Co., Ltd 1936c5f4-274b-8e49-e063-6394a90ac642 2024-11-21 Warnings Exact identifier application number: M017 Hempvana Ultra Strength Pain Relief Cream Platinum 4% Lidocaine LIDOCAINE 4% Telebrands Corp 2788189e-35bc-d48c-e063-6294a90ae6c2 2024-11-21 Warnings Exact identifier application number: M017 Family Wellness Ultra Strength Muscle Rub ULTRA STRENGTH MUSCLE RUB FAMILY DOLLAR (Family Wellness) 554c7d3c-09f4-4923-b4ca-d5de8f7e2c9a 2024-11-21 Warnings Exact identifier application number: M017 Family Wellness Anorectal Lidocaine ANORECTAL LIDOCAINE FAMILY DOLLAR (Family Wellness) ed7e0cdc-ca4b-47ba-b82b-49fb4913ef8d 2024-11-21 Warnings Exact identifier application number: M017 Family Wellness Hot and Cold Pain Relief HOT AND COLD PAIN RELIEF FAMILY DOLLAR (Family Wellness) b70e343b-18aa-4e45-ae8e-79d8c84ad205 2024-11-21 Warnings Exact identifier application number: M017 Signature Care Lidocaine Cream LIDOCAINE Better Living Brands LLC 5483729e-ef1a-47a2-b7cf-c19744f52073 2024-11-21 Warnings Exact identifier application number: M017 WINCO Hydrocortisone HYDROCORTISONE 1% WinCo Foods LLC 26a29de3-4b79-4a3a-93b6-a14c5e91a8c6 2024-11-21 Warnings Exact identifier application number: M017 Menthol and Zinc Oxide MENTHOL AND ZINC OXIDE Dynarex Corporation d0e43651-4215-465b-9ace-1bc23126b109 2024-11-20 Warnings Exact identifier application number: M017 Hempvana Cold As Ice Pain Relief Gel-Patch MENTHOL Telebrands Corp 976a1bb2-b776-8199-e053-2995a90a1a1b 2024-11-20 Warnings Exact identifier application number: M017 Hempvana Maximum Strength Pain Relief TROLAMINE SALICYLATE TELEBRANDS CORP d91a0fad-a38c-1580-e053-2a95a90ad268 2024-11-20 Warnings Exact identifier application number: M017 Hempvana Maximum Strength Pain Relief - Platinum TROLAMINE SALICYLATE TELEBRANDS CORP d58da6c5-47a6-b8a8-e053-2995a90a7ce7 2024-11-20 Warnings Exact identifier application number: M017 Hempvana Knee Bird Ultra Strength Pain Relief LIDOCAINE, MENTHOL TELEBRANDS CORP df5d3312-cbc5-5db9-e053-2995a90ab055 2024-11-20 Warnings Exact identifier application number: M017 Hempvana Cold as Ice Gel MENTHOL Telebrands Corp a9e103f2-778f-e49b-e053-2a95a90aa8b7 2024-11-20 Warnings Exact identifier application number: M017 Hempvana Knee Bird Ultra Strength Pain Relief LIDOCAINE, MENTHOL TELEBRANDS CORP d58e2c47-c0f4-625e-e053-2a95a90aa4d5 2024-11-20 Warnings Exact identifier application number: M017 Hempvana Pain Relief TROLAMINE SALICYLATE Telebrands Corp 92a29553-a102-0a0e-e053-2a95a90ab24a 2024-11-20 Warnings Exact identifier application number: M017
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 51879-802-06 51879080206 1 BOTTLE in 1 CARTON (51879-802-06) > 178.9 g in 1 BOTTLE (51879-802-66) 1 bottle 2019-06-20 0000-00-00 No No Current 51879-802-16 51879080216 1.86 g in 1 PACKET 1.86 g Historical 51879-802-44 51879080244 144 PACKET in 1 CARTON (51879-802-44) / 1.86 g in 1 PACKET (51879-802-16) 144 packet 2019-07-23 0000-00-00 No No Current 51879-802-66 51879080266 178.9 g in 1 BOTTLE (51879-802-66) 178.9 g 2019-06-20 0000-00-00 No No Current