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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	51879-802	51879-802-06	D	Discontinued by firm		2026-10-15

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 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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
8bc9cbfe-1dd4-18ed-e053-2a95a90a7966	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0e2e0f88-b076-afe1-4bdd-32bca4375bec	Product name	3	20250127
777d68c6-a5ab-e06c-d314-677b0b9af0c8	Product name	2	20240508
190f2a5b-bbc8-65c7-fcb0-97891307b917	Product name	1	20140508
3e48c9c4-918d-5d23-2f0b-d2398b06be54	Product name	1	20140508
865c72dd-0d94-daac-f728-ddd4ded2a79e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	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 17 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MyDerm Aloe and Lidocaine	LIDOCAINE	Medline Industries	fdfd4388-cd27-467b-959b-249a49ea5cf6	2026-05-26	Warnings	Exact identifier application number: M017
MyDerm Aloe and Lidocaine	LIDOCAINE	Inspec Solutions LLC.	4939c663-a876-4527-822a-df02964fa694	2026-05-26	Warnings	Exact identifier application number: M017
Lidocaine Menthol Pain Relief	LIDOCAINE, MENTHOL	Amerisource Bergen	94039190-dde3-4d8e-873a-79abd3f6208b	2026-05-26	Warnings	Exact identifier application number: M017
topcare hydrocortisone	HYDROCORTISONE	Topco Associates LLC	858053a0-d888-4bb9-b94e-503bcf3864cb	2026-05-21	Warnings	Exact identifier application number: M017
Arthritis Pain Relief Cream	HISTAMINE DIHYDROCHLORIDE	Sombra Cosmetics Inc.	523333ee-eccd-bcf7-e063-6394a90aea60	2026-05-21	Warnings	Exact identifier application number: M017
North Star Nutritionals Soothanol X3 Pain Relieving Drops	MENTHOL	NEWMARKET HEALTH PRODUCTS, LLC	068343b8-0435-40d0-846c-9d8624e8b6c4	2026-05-21	Warnings	Exact identifier application number: M017
DO ME DELAY	LIDOCAINE HCL	Prodigy Media Inc	5255ee85-6f29-0776-e063-6394a90a525b	2026-05-21	Warnings	Exact identifier application number: M017
Australian Dream Back Pain	HISTAMINE DIHYDROCHLORIDE	Sombra Cosmetics Inc.	5256a63e-e6da-84c1-e063-6294a90a8dff	2026-05-21	Warnings	Exact identifier application number: M017
SINSIN HANBANG FLEX	CAMPHOR, MENTHOL	Sinsin Pharmaceutical co., ltd.	525c5d18-bfc1-3002-e063-6394a90a5b1d	2026-05-21	Warnings	Exact identifier application number: M017
LidoPro Patch	LIDOCAINE, MENTHOL, AND METHYL SALICYLATE	Preferred Pharmaceuticals Inc.	6c9a076e-6316-427b-9ce6-c8fe2d388837	2026-05-21	Warnings	Exact identifier application number: M017
Medi-First Capsaicin Cream	CAPSAICIN	Unifirst First Aid Corporation	49eb807b-fa31-3d84-e063-6394a90acfcf	2026-05-20	Warnings	Exact identifier application number: M017
Biofreeze Triple Target Roll-On	CAMPHOR, CAPSAICIN, MENTHOL	Reckitt Benckiser LLC	5089c088-3026-233a-e063-6394a90a93b6	2026-05-19	Warnings	Exact identifier application number: M017
Lidocaine Pain Relief Patch	LIDOCAINE	GERI-CARE PHARMACEUTICAL CORP	522f1521-f9f2-4c26-e063-6394a90a9e05	2026-05-19	Warnings	Exact identifier application number: M017
Easment 0.1% Capsaicin Roll on	CAPSAICIN 0.1%	Easment LLC	521212d6-57fd-4a7a-e063-6294a90a2a18	2026-05-18	Warnings	Exact identifier application number: M017
Burn Relief	LIDOCAINE	WALMART INC.	15af4557-4baf-c177-e063-6294a90a7a5b	2026-05-18	Warnings	Exact identifier application number: M017
Blistex Maximum Hydration Lip	CAMPHOR (SYNTHETIC), DIMETHICONE, UNSPECIFIED, MENTHOL, UNSPECIFIED FORM, AND PHENOL	Blistex Inc.	fed223bc-edf3-46eb-b678-acb906f9ef11	2026-05-18	Warnings	Exact identifier application number: M017
Tiger Balm	CAMPHOR (SYNTHETIC), MENTHOL, AND CAPSICUM	Haw Par Healthcare Ltd.	5066dc10-e4d5-49e9-9a5f-0ac220cfbf28	2026-05-18	Warnings	Exact identifier application number: M017
Deep Blue Mini	MENTHOL	doTERRA International, LLC	51dd58a8-1fd5-9cd7-e063-6394a90a1f72	2026-05-15	Warnings	Exact identifier application number: M017
Biofreeze Overnight Gel	MENTHOL	Reckitt Benckiser LLC	f5c8c08b-c7c0-f84d-e053-2a95a90add15	2026-05-15	Warnings	Exact identifier application number: M017
Biofreeze Professional	MENTHOL, UNSPECIFIED FORM	Reckitt Benckiser LLC	00bba5d2-b0e0-701c-e063-6294a90a5741	2026-05-15	Warnings	Exact identifier application number: M017

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
TC2D6JAD40	DIPHENHYDRAMINE HYDROCHLORIDE	147-24-0	DIPHENHYDRAMINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2174801	CALAGEL 2 % Topical Gel	PSN	8bc9cbfe-1dd4-18ed-e053-2a95a90a7966	8
1049880	diphenhydrAMINE HCl 2 % Topical Gel	PSN	8bc9cbfe-1dd4-18ed-e053-2a95a90a7966	8
2174801	diphenhydramine hydrochloride 0.02 MG/MG Topical Gel [Calagel Reformulated Jun 2019]	SBD	8bc9cbfe-1dd4-18ed-e053-2a95a90a7966	8
1049880	diphenhydramine hydrochloride 0.02 MG/MG Topical Gel	SCD	8bc9cbfe-1dd4-18ed-e053-2a95a90a7966	8
2174801	Calagel Reformulated Jun 2019 0.02 MG/MG Topical Gel	SY	8bc9cbfe-1dd4-18ed-e053-2a95a90a7966	8
2174801	Calagel Reformulated Jun 2019 2 % Topical Gel	SY	8bc9cbfe-1dd4-18ed-e053-2a95a90a7966	8
1049880	diphenhydramine hydrochloride 2 % Topical Gel	SY	8bc9cbfe-1dd4-18ed-e053-2a95a90a7966	8

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