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 90 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Re-Lieved Lidocaine PatchLIDOCAINE PATCH 4%Transfer Technology37ef02d4-2ff5-cb23-e063-6294a90a68af2025-06-19WarningsExact identifier
application number: M017
Post-Treatment Repair CreamHYDROCORTISONEVi Medical Products Inc.ab8885a9-0778-28ff-e053-2995a90a2e122025-06-19WarningsExact identifier
application number: M017
MyDermLIDOCAINEInspec Solutions LLC.82d075d1-c92e-2097-e053-2991aa0ab1312025-06-18WarningsExact identifier
application number: M017
Walgreens Extra Small LidocaineLIDOCAINEWalgreen Co.dc838e47-d234-4ba5-9449-f645e99be9232025-06-18WarningsExact identifier
application number: M017
CLn Body MoisturizerCOLLOIDAL OAT MOISTURIZERTopMD Skin Care, Inc.2de3d68d-a540-d456-e063-6394a90a4b572025-06-18WarningsExact identifier
application number: M017
Aloe UP SPF 30 MineralZINC OXIDE, TITANIUM DIOXIDEAloe Care International, LLC35967b33-bdfb-ee3c-e063-6294a90a75f62025-06-18WarningsExact identifier
application number: M017
Aloe Up SPF 50 MineralZINC OXIDE, TITANIUM DIOXIDEAloe Care International, LLC35b9dcfa-05f3-3d7b-e063-6394a90a18f12025-06-18WarningsExact identifier
application number: M017
Aloe Up SPF 50 MineralZINC OXIDEAloe International, LLC35bc3621-f4e4-42d3-e063-6394a90a7aad2025-06-18WarningsExact identifier
application number: M017
Aloe Up SPF 50 Kids MineralZINC OXIDE, TITANIUM DIOXIDEAloe Care International, LLC35cd16b0-bd81-8f68-e063-6294a90a3d8c2025-06-18WarningsExact identifier
application number: M017
Aloe Up SPF 50 Kids MineralZINC OXIDEAloe International, LLC35cd5542-947d-a042-e063-6394a90a13f82025-06-18WarningsExact identifier
application number: M017
Relieve Your PainMENTHOLProximity Capital Partners LLC dba Asutrac12369dd-8305-edaf-e053-2995a90a0d3d2025-06-18WarningsExact identifier
application number: M017
Melt Pain AwayCAPSAICINProximity Capital Partners LLC dba Asutraa95a11d7-a2ae-6654-e053-2a95a90a802c2025-06-18WarningsExact identifier
application number: M017
Recovery Roll-OnMENTHOL, CAMPHORPROXIMITY CAPITAL PARTNERS LLC DBA ASUTRAebc9630f-6d8b-e4f0-e053-2995a90a0b492025-06-18WarningsExact identifier
application number: M017
ProCure Hydrocortisone 1%HYDROCORTISONETwin Med LLC37cdfabc-1fdb-246a-e063-6394a90a008a2025-06-17WarningsExact identifier
application number: M017
ProCure Hydrocortisone 1%HYDROCORTISONETwin Med LLC37ce6c35-b211-43de-e063-6294a90ab7732025-06-17WarningsExact identifier
application number: M017
Hydrocortisone with AloeHYDROCORTISONE CREAM 1%Sun Pharmaceutical Industries, Inc.312ddc8d-100e-cfac-e063-6294a90acd092025-06-16WarningsExact identifier
application number: M017
Curist 5% LidocaineLIDOCAINE 5%Little Pharma, Inc.f20241a2-c5b1-f124-e053-2995a90a891b2025-06-16WarningsExact identifier
application number: M017
Toast Screamin MentholMENTHOLIDEAZ, LLC37b48b1a-ef3d-afdc-e063-6294a90a66102025-06-16WarningsExact identifier
application number: M017
Toast Freezin ColdMENTHOL, METHYL SALICYLATEIDEAZ, LLC37b4d363-0099-8cd3-e063-6394a90a18d62025-06-16WarningsExact identifier
application number: M017
Earths Care Anti-ItchCAMPHOR (NATURAL) AND MENTHOL, UNSPECIFIED FORMDLC Laboratories, Inc.ba65f58a-d590-498a-b8e7-a3d78935d8802025-06-13WarningsExact 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