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 149 of 152 · 3,029 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join FEEL GOOD LABS NATURAL PAIN MENTHOL The Feel Good Lab 778b62a1-ebd3-4a30-8f76-6d6773b698c5 2023-11-05 Warnings Exact identifier application number: M017 FEEL GOOD LABS SPORT RECOVERY MENTHOL The Feel Good Lab 103c5e33-42fb-41ac-957e-bb46d85e204c 2023-11-05 Warnings Exact identifier application number: M017 INSTA RELIEF DM LIDOCAINE HYDROCHLORIDE, MENTHOL DM LAB CORP 6ef66fb9-9f49-409d-9503-175c7555ee9e 2023-11-05 Warnings Exact identifier application number: M017 DR. MIKES Ponos Pain Relief Cream Roll-On HISTAMINE DIHYDROCHLORIDE, MENTHOL Dr. Mike's Vitamins, LLC fcc45464-f1fe-4244-95a7-9b4288b0ce45 2023-11-05 Warnings Exact identifier application number: M017 AcuPlus Pain Relief MENTHOL Innovations for Wellness, LLC 7f222a4f-85a8-4f3d-aa97-5c695d4da37f 2023-11-05 Warnings Exact identifier application number: M017 Ana Cool Rapid Soothing Cooling Formula HYDROCORTISONE Ana-Cool, LLC 64b80cc2-e2d8-4535-aaf8-c031f4159cd1 2023-11-05 Warnings Exact identifier application number: M017 FEEL GOOD LABS SPORT RECOVERY MENTHOL THE FEEL GOOD LAB, LLC 19b08cbf-5f43-4f07-8f4d-8cddb1492ab8 2023-11-05 Warnings Exact identifier application number: M017 PlayMakar Roll On Cool Pain Relief MENTHOL PlayMakar Inc. a12c16e7-561f-45a7-93c6-34d693ffdc7c 2023-11-05 Warnings Exact identifier application number: M017 AcuPlus Advanced Therapy for Pain and Recovery MENTHOL INNOVATIONS FOR WELLNESS, LLC 840cfd15-4ea1-49bf-8c4f-86c12461d860 2023-11-05 Warnings Exact identifier application number: M017 SCLERA CARE Topical Anesthetic Gel LIDOCAINE HYDROCHLORIDE ScleraCare, LLC 488ace02-fc0b-4d13-ab89-0e1640e915e5 2023-11-05 Warnings Exact identifier application number: M017 IRELIEV ROLL ON COOL PAIN RELIEF MENTHOL Excel Health, Inc dab94995-7393-4d9c-b295-72611a90919b 2023-11-05 Warnings Exact identifier application number: M017 URIFLEX Fast Acting Analgesic Pain Relief MENTHOL Rejuvica LLC fb78f705-b838-461d-b42c-8c98d3ca5d09 2023-11-05 Warnings Exact identifier application number: M017 365 Medicated Lip Balm MEDICATED LIP BALM Whole Foods Market, Inc. 48309a7d-d2da-483c-8bf8-f59d9ad0bb73 2023-11-03 Warnings Exact identifier application number: M017 COOL BREEZE Pain Relief MENTHOL COOL BREEZE US LLC 14dcf4ee-6778-49d4-8601-9205737432ea 2023-11-01 Warnings Exact identifier application number: M017 Lidozen LIDOCAINE HYDROCHLORIDE, MENTHOL Proficient Rx LP 1ebb45e5-4541-4c95-abe1-661ef763a610 2023-11-01 Warnings Exact identifier application number: M017 Walgreens Pain Relieving Cream LIDOCAINE 4% Walgreens ce1b55ed-f5c5-ea8b-e053-2a95a90acd40 2023-10-31 Warnings Exact identifier application number: M017 Walgreens pain relieving LIDOCAINE 4% Walgreens ce2b9e57-749d-715c-e053-2995a90aaf8d 2023-10-31 Warnings Exact identifier application number: M017 Walgreens Cool n heat LIDOCAINE 4% MENTHOL 1% Walgreens ce168ab7-ec4a-daea-e053-2995a90af829 2023-10-31 Warnings Exact identifier application number: M017 Methyl Salicylate 40 Percent METHYL SALICYLATE Alexso, Inc 53407aab-094c-4393-a2b9-54fd85321e3e 2023-10-31 Warnings Exact identifier application number: M017 Hydrocortisone Acetate HYDROCORTISONE ACETATE Bentlin Products LLC 4346351c-8e11-46ae-b428-98d17f55beb9 2023-10-30 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