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 firm2026-10-20

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 101 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Menthol Pain Relief Gel-Roll OnMENTHOLGuangzhou Liuquanmiao Import & Export Trade Co., Ltd.0bd62de8-ce8b-c110-e063-6294a90a98cb2025-02-07WarningsExact identifier
application number: M017
Menthol Pain Relief Gel-TubeMENTHOLGuangzhou Liuquanmiao Import & Export Trade Co., Ltd.0bb07892-824e-8691-e063-6294a90a38912025-02-07WarningsExact identifier
application number: M017
Olu Pain ManagementLIDOCAINE AND CAMPHOROlakino Therapeutics LLC2a41a621-c6f7-5819-e063-6394a90ae67d2025-02-07WarningsExact identifier
application number: M017
Pain Reliveing PatchLIDOCAINE 4%simple diagnostics02ed0b27-bba9-ec0c-e063-6294a90a014d2025-02-07WarningsExact identifier
application number: M017
FlexDermal Pain Relieving Roll-OnMENTHOLSOLVADERM LLCd4d8050e-0761-4491-8635-39c806701eb52025-02-06WarningsExact identifier
application number: M017
Lipo Flavonoid Ear Pain Relief Drops with 4% LidocaineLIPO FLAVONOID EAR PAIN RELIEF DROPS WITH 4% LIDOCAINEClarion Brands LLC2d7e9f6a-0f21-b103-e063-6294a90a912f2025-02-06WarningsExact identifier
application number: M017
signature care HydrocortisoneHYDROCORTISONESafeway9fe16fc5-77e3-47f5-a943-85bc6565c0d42025-02-06WarningsExact identifier
application number: M017
Methyl SalicylateMETHYL SALICYLATEPHARMACURE LLC8803ae01-ea48-46c2-ab64-bb273de605ac2025-02-05WarningsExact identifier
application number: M017
Hempvana Maximum Strength Pain Relief Cream 10% Trolamine SalicylateTROLAMINE SALICYLATETELEBRANDS CORP2d685602-5cd6-3b36-e063-6394a90a3c5d2025-02-05WarningsExact identifier
application number: M017
LidocoreLIDOCAINEiON Pharma, LLC204c3e50-1ac8-f442-e063-6294a90ae7b52025-02-05WarningsExact identifier
application number: M017
Methyl SalicylateMETHYL SALICYLATEPHARMACURE LLC2c32cfed-2022-4e7c-ae9c-ba22dbb560af2025-02-04WarningsExact identifier
application number: M017
CapsaicinCAPSAICINPHARMACURE LLCb2b2de93-d957-43d7-a2a8-b46bcaea1f0d2025-02-04WarningsExact identifier
application number: M017
Hempvana Maximum Strength Pain Relief Cream ExtremeMENTHOL 16%, CAMPHOR 11%Telebrands Corp2d54077e-4c8d-aaae-e063-6394a90adb412025-02-04WarningsExact identifier
application number: M017
Capsaicin External AnalgesicCAPSAICINNuCare Pharmaceuticals,Inc.fd90a67d-d60d-a849-e053-6394a90a2cc82025-02-04WarningsExact identifier
application number: M017
Rugby Muscle Rub CreamMUSCLE RUB CREAMNuCare Pharmaceuticals, Inc.2d58c15a-5ddb-1b16-e063-6294a90a3fbb2025-02-04WarningsExact identifier
application number: M017
CetilarMENTHOL 1.4%PharmaNutra Usa Corp.2dd14bd4-b4e1-bc7d-e063-6394a90a1e592025-02-04WarningsExact identifier
application number: M017
Stopain Extra Strength ContinuousMENTHOLTroy Manufacturing, Inc.0d199d39-5b47-4c7f-b83a-757f39aa17b62025-02-03WarningsExact identifier
application number: M017
TheraCare Pain Relieving Lidocaine CreamLIDOCAINE HYDROCHLORIDEVeridian Healthcare2d42192b-8889-a896-e063-6294a90a4fc82025-02-03WarningsExact identifier
application number: M017
Tiger Balm Pain Relieving MuscleMETHYL SALICYLATE, MENTHOL, UNSPECIFIED FORM, AND CAMPHOR (SYNTHETIC)Haw Par Healthcare Ltd.96b06d3f-8685-4314-ad7d-5d2720f4dde62025-02-03WarningsExact identifier
application number: M017
Icy Hot Medicated No Mess ApplicatorMENTHOLChattem, Inc.4ce2b823-7ef5-4cca-a2d8-2fe781bc958e2025-02-01WarningsExact 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