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 firm2026-10-15

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 54 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Welly First Aid Kit RefillHYDROCORTISONE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINEDongguan Shenglian Tins Products Co., Ltd.4bc93855-4009-4b49-9fb4-e5864054153d2025-12-16WarningsExact identifier
application number: M017
LidocainePain pain reliving gel-patchPAIN RELIVING GEL-PATCHShenzhen Yuetai Electronic Commerce Co., Ltd461ebbdd-0f26-a333-e063-6394a90a7a3e2025-12-16WarningsExact identifier
application number: M017
ZestamaCAPSAICINV2 Pharma LLCc9b46759-b8df-4ff4-815e-8e032c2635c02025-12-15WarningsExact identifier
application number: M017
equate hydrocortisoneHYDROCORTISONEWal-Mart Stores Inc70f4636d-4137-498b-ab81-0330de883e532025-12-15WarningsExact identifier
application number: M017
SALONPAS-HOT CAPSICUMCAPSAICINHisamitsu Pharmaceutical Co., Inc.ef5373aa-9857-4d01-95af-2d7716e54ae42025-12-15WarningsExact identifier
application number: M017
First Aid Burn CreamFIRST AID BURN CREAMProStat First Aid LLCf70a442e-7ba7-4860-e053-6394a90ac2bd2025-12-15WarningsExact identifier
application number: M017
Burn Ease, 3.5gBURN EASE, 3.5GProStat First Aid LLC004aa18f-3a97-f454-e063-6394a90afcff2025-12-15WarningsExact identifier
application number: M017
PS-3866 Burn Ease, 0.9gPS-3866 BURN EASE, 0.9GProStat First Aid LLC004d00a5-9cff-29ff-e063-6294a90aeb8c2025-12-15WarningsExact identifier
application number: M017
First Aid Burn CreamFIRST AID BURN CREAMProStat First Aid LLC0037a1a4-d747-2567-e063-6394a90a721c2025-12-15WarningsExact identifier
application number: M017
PS-3885 Burn Ease, 3.5gPS-3885 BURN EASE, 3.5GProStat First Aid LLC004c6deb-2844-a0d0-e063-6394a90ae5e42025-12-15WarningsExact identifier
application number: M017
2677 First Aid Burn Cream2677 FIRST AID BURN CREAMProStat First Aid LLCff5bb628-8ef7-4540-e053-6394a90a55ed2025-12-15WarningsExact identifier
application number: M017
Burn EaseBURN EASEProStat First Aid LLCf71b98b4-22d0-0124-e053-6394a90ae4cf2025-12-15WarningsExact identifier
application number: M017
Burn EaseBURN EASEProStat First Aid LLCf71eb4f5-2280-5867-e053-6394a90aac572025-12-15WarningsExact identifier
application number: M017
Burn Ease 3.5gBURN EASE 3.5GFront Line Safety0f8e6842-c889-d5d3-e063-6394a90af8802025-12-15WarningsExact identifier
application number: M017
Burn Ease 3.5gBURN EASE 3.5GFront Line Safety0f8c59fb-3622-2bb7-e063-6294a90adc6e2025-12-15WarningsExact identifier
application number: M017
Burn EaseBURN EASEFront Line Safety0e34cb09-d8c6-f8c0-e063-6294a90a0be02025-12-15WarningsExact identifier
application number: M017
Burn Ease 3.5gBURN EASE 3.5GFront Line Safety0f52021f-af8a-5b95-e063-6294a90a2c2a2025-12-15WarningsExact identifier
application number: M017
Burn EaseBURN EASEProStat First Aid LLC0e25c936-e40a-e23c-e063-6294a90ac0e42025-12-15WarningsExact identifier
application number: M017
Sting Relief WipesSTING RELIEF WIPESProStat First Aid LLC0e20252a-5ecb-2526-e063-6294a90a8cde2025-12-15WarningsExact identifier
application number: M017
First Aid Burn CreamFIRST AID BURN CREAMFront Line Safety0f4ce2c2-f306-d95f-e063-6394a90ae7b32025-12-15WarningsExact 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