FDA.reportPublic FDA data

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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage51879-80251879-802-06DDiscontinued by firm2026-10-16

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 dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage51879-80251879-802-06DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…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
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE20 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
TC2D6JAD40Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1049880Internal RxNorm lookup
2174801Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8bc9cbfe-1dd4-18ed-e053-2a95a90a7966Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51879-802-06Tecnu Calagel1 in 1 CARTONGEL18
51879-802-16Tecnu Calagel1.86 g in 1 PACKETGEL1.868
51879-802-44Tecnu Calagel144 in 1 CARTONGEL1448
51879-802-66Tecnu Calagel178.9 g in 1 BOTTLEGEL178.98

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51879-802TECNU CALAGEL (DIPHENHYDRAMINE HYDROCHLORIDE) GEL [TEC LABORATORIES INC.]6Current NDC, Legacy NDC, 4 package rows20241107_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 69 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Topcare Cold and Hot MedicatedMENTHOLTopco Associates LLC8739aedd-165c-5ae0-e053-2a91aa0afcd02025-10-31WarningsExact identifier
application number: M017
CVS Medicated Heat 1 ctCAPSAICINCVS Pharmacy, Inc.d41dce5b-e698-4930-8869-040b2a973f252025-10-31WarningsExact identifier
application number: M017
Coralite Medicated HeatCAPSAICINUnited Exchange Corp.a0b89c7e-80bc-43c4-840c-5fd567f60b212025-10-31WarningsExact identifier
application number: M017
Dragon with Arnical Pain ReliefMENTHOLGenomma Lab USA Inc.b4cbb7b6-cb71-9721-e053-2995a90a2b2c2025-10-31WarningsExact identifier
application number: M017
Hydrocortisone Anti-ItchHYDROCORTISONEUniversal Distribution Center LLC186afb11-06b6-4bfa-e063-6294a90aefc62025-10-30WarningsExact identifier
application number: M017
Gemachlich ZuHause NEUROPATHY SOLID Ointment.GEMACHLICH ZUHAUSE NEUROPATHY SOLID OINTMENT.Guangdong Quadrant Ecological Technology Co., Ltd.425b1b9d-c33a-05e9-e063-6394a90a97a62025-10-30WarningsExact identifier
application number: M017
Gemachlich ZuHause NEUROPATHY Spray.GEMACHLICH ZUHAUSE NEUROPATHY SPRAY.Guangdong Quadrant Ecological Technology Co., Ltd.425b8259-af38-8d68-e063-6394a90a11202025-10-30WarningsExact identifier
application number: M017
Family Care Muscle and JointMENTHOLUnited Exchange Corp.959af9f4-7188-91a1-e053-2995a90a46652025-10-30WarningsExact identifier
application number: M017
CVS Maximum Strength Boil ReliefBENZOCAINECVS Pharmacy, Inc.0761b866-af34-42bd-adc9-3d229170d01c2025-10-30WarningsExact identifier
application number: M017
CVS Cold and HotMENTHOLCVS Pharmacya44ca52d-fec8-0e8c-e053-2995a90a2e602025-10-30WarningsExact identifier
application number: M017
CVS CAPSAICINCAPSAICINCVS PHARMACY9b551fe3-3842-482a-9042-63de5ad398842025-10-30WarningsExact identifier
application number: M017
TopCare Health Pain ReliefMENTHOL, CAMPHOR, AND METHYL SALICYLATETopco Associates LLCdac364ef-6dcd-3fc6-e053-2a95a90a9bb22025-10-30WarningsExact identifier
application number: M017
Calamine PlusCALAMINE PLUS PRAMOXINE HCLAmerisourceBergen Drug Corporationf161e151-4fab-2fbc-e053-2a95a90a54372025-10-30WarningsExact identifier
application number: M017
LidocaineBURN RELIEFPerrigo Directc7b50f14-3481-9ebd-e053-2995a90afe1c2025-10-30WarningsExact identifier
application number: M017
Lipoflavonoid Ear Pain Kids Relief DropsLIPOFLAVONOID EAR PAIN KIDS RELIEF DROPSClarion Brands LLC4265361b-5526-c3e0-e063-6394a90a17772025-10-30WarningsExact identifier
application number: M017
Diphenhydramine HCl and Zinc AcetateEXTRA STRENGTH ITCH RELIEFHEB2aedbf1d-c8b7-4d5d-83ee-e38872c37d4f2025-10-30WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONE SPRAYMeijer Distribution Inc.28daaf97-b0b3-7a54-e063-6294a90a23f12025-10-30WarningsExact identifier
application number: M017
Calamine PlusCALAMINE PLUS PRAMOXINE HCLMeijer Distribution Inc.03c46823-0b1f-4101-e063-6294a90aaf942025-10-30WarningsExact identifier
application number: M017
Extra Strength Itch ReliefDIPHENHYDRAMINE HCL AND ZINC ACETATEMeijer Distribution Inc02f9e270-6047-83b6-e063-6394a90afc272025-10-30WarningsExact identifier
application number: M017
Muscle Rub Pain Reliever GelMENTHOL, UNSPECIFIED FORMUniversal Distribution Centre LLC18536e21-afc3-8447-e063-6394a90aabae2025-10-30WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2174801CALAGEL 2 % Topical GelPSN8bc9cbfe-1dd4-18ed-e053-2a95a90a79668
1049880diphenhydrAMINE HCl 2 % Topical GelPSN8bc9cbfe-1dd4-18ed-e053-2a95a90a79668
2174801diphenhydramine hydrochloride 0.02 MG/MG Topical Gel [Calagel Reformulated Jun 2019]SBD8bc9cbfe-1dd4-18ed-e053-2a95a90a79668
1049880diphenhydramine hydrochloride 0.02 MG/MG Topical GelSCD8bc9cbfe-1dd4-18ed-e053-2a95a90a79668
2174801Calagel Reformulated Jun 2019 0.02 MG/MG Topical GelSY8bc9cbfe-1dd4-18ed-e053-2a95a90a79668
2174801Calagel Reformulated Jun 2019 2 % Topical GelSY8bc9cbfe-1dd4-18ed-e053-2a95a90a79668
1049880diphenhydramine hydrochloride 2 % Topical GelSY8bc9cbfe-1dd4-18ed-e053-2a95a90a79668

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51879-802-06518790802061 BOTTLE in 1 CARTON (51879-802-06) > 178.9 g in 1 BOTTLE (51879-802-66) 1 bottle2019-06-200000-00-00NoNoCurrent
51879-802-16518790802161.86 g in 1 PACKET1.86 gHistorical
51879-802-4451879080244144 PACKET in 1 CARTON (51879-802-44) / 1.86 g in 1 PACKET (51879-802-16) 144 packet2019-07-230000-00-00NoNoCurrent
51879-802-6651879080266178.9 g in 1 BOTTLE (51879-802-66) 178.9 g2019-06-200000-00-00NoNoCurrent