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		2026-10-16

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 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 55 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Magsoothium Body	MENTHOL, CAPSAICIN	Ubu/Elements, Inc.	f604d30c-b17c-ec01-e053-2a95a90aa304	2025-12-15	Warnings	Exact identifier application number: M017
Salonpas pain relieving JET	MENTHOL, METHYL SALICYLATE	Hisamitsu Pharmaceutical Co., Inc.	dd1ea3bf-891a-402e-8f43-14302bc9c3e5	2025-12-15	Warnings	Exact identifier application number: M017
Herbal Tendon Bone Relief	CAMPHOR MINT	Guchutang Biotechnology (Longyan) Co., Ltd.	45cf4040-9751-d24b-e063-6294a90aff27	2025-12-13	Warnings	Exact identifier application number: M017
ElixirLidoFast	LIDOCAINE 5% CREAM	ELIXIR HEALTHCARE USA, LLC.	45de5a3d-06c2-aa02-e063-6294a90a63d3	2025-12-13	Warnings	Exact identifier application number: M017
MEDI FIRST PLUS	HYDROCORTISONE ACETATE	Orazen Inc	5781124a-60f4-4a64-80b7-ce5f28d495b5	2025-12-12	Warnings	Exact identifier application number: M017
MEDI-FIRST	HYDROCORTISONE ACETATE	Orazen Inc	aeffd85c-58a7-4d64-bf94-977b6fbbe713	2025-12-12	Warnings	Exact identifier application number: M017
Joint and Muscle Relief	MENTHOL	Smart Cookie Solutions Inc.	45c24d56-4dc9-2884-e063-6294a90a52cc	2025-12-12	Warnings	Exact identifier application number: M017
Popstar	DELAY SPRAY	Pineapple Brands LLC	293b2da9-1261-0358-e063-6394a90aa08c	2025-12-12	Warnings	Exact identifier application number: M017
Careland Pain Relief Plus	CAMPHOR, MENTHOL, METHYL SALICYLATE	Planet (Anhui) Pharmaceutical Co., Ltd.	d9e63ddd-d003-45fa-b156-7f4452c28cbd	2025-12-12	Warnings	Exact identifier application number: M017
Glucosamine Cream EXTRA STRENGTH	HISTAMINE DIHYDROCHLORIDE	IDEAZ, LLC	f4d414b7-89e7-ad65-e053-2a95a90a25d4	2025-12-12	Warnings	Exact identifier application number: M017
ARTHRITIS	MENTHOL	Smith Amish, LLC	20c36972-b695-1241-e063-6394a90adf63	2025-12-12	Warnings	Exact identifier application number: M017
FOOT	MENTHOL	Smith Amish, LLC	20c48537-f55f-c10f-e063-6394a90a4cca	2025-12-12	Warnings	Exact identifier application number: M017
Joint Ease	MENTHOL	Smith Amish, LLC	20c4a0f8-bdc6-d89a-e063-6294a90aa8d8	2025-12-12	Warnings	Exact identifier application number: M017
Toast Screamin Hot	CAPSAICIN	IDEAZ, LLC	331207e6-b8ac-b169-e063-6394a90ac169	2025-12-12	Warnings	Exact identifier application number: M017
Pain Relief Gel-Patch	LIDOCAINE	KORVIA GLOBAL Inc.	45ccfcae-a307-1c5f-e063-6294a90acf89	2025-12-12	Warnings	Exact identifier application number: M017
Lidospot patch	LIDOCAINE AND MENTHOL	Fabrication Enterprises Inc	3a6e94c4-1ca6-e77a-e063-6394a90a4bfc	2025-12-12	Warnings	Exact identifier application number: M017
LETEBEE LIGHT neuropathy pain relief cream for feet	MENTHOL	Guangdong Aimu Biological Technology Co., Ltd	45a99afc-15ec-76c2-e063-6294a90a2220	2025-12-11	Warnings	Exact identifier application number: M017
Cinthera	LIDOCAINE	Strand Health Group	2746e5b2-be2d-f2d2-e063-6394a90a3690	2025-12-11	Warnings	Exact identifier application number: M017
Equate Cool and Heat Pain Relieving Liquid	COOL AND HEAT PAIN RELIEF	Walmart, Inc.	ad156685-3bd5-6837-e053-2995a90ac788	2025-12-11	Warnings	Exact identifier application number: M017
HUMCO Camphor Spirit	CAMPHOR 10%	Humco Holding Group, Inc.	9a0ef0a3-3c79-41b2-8193-424a3ef9886f	2025-12-11	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