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		2026-10-21

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 133 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HealthWise 3x Medicated Pain Relief Patch	CAMPHOR,MENTHOL, METHYL SALICYLATE	Veridian Healthcare	164d4d62-00c0-e06d-e063-6294a90abd73	2024-04-17	Warnings	Exact identifier application number: M017
TIGER Balm PAIN RELIEVING HYDROGEL	CAMPHOR (SYNTHETIC), LEVOMENTHOL, AND CAPSICUM	Haw Par Healthcare Ltd.	ca601b02-e9be-4d8d-a384-c62553302ceb	2024-04-16	Warnings	Exact identifier application number: M017
Lidocaine Pain Relief Patch	LIDOCAINE PAIN RELIEF PATCH	Henan Enokon Medical Instrument Co., Ltd.	1592a40a-a647-34bd-e063-6394a90a0a10	2024-04-08	Warnings	Exact identifier application number: M017
Menticam	CAMPHOR, MENTHOL, METHYL SALICYLATE	PureTek Corporation	081837a8-9669-be1f-e063-6394a90a9d20	2024-04-05	Warnings	Exact identifier application number: M017
Pain Relieving Liniment	CAMPHOR (NATURAL) AND MENTHOL, UNSPECIFIED FORM	J.R. Watkins, LLC.	97a0c839-0927-4e54-aee2-ded2016ac4a0	2024-04-02	Warnings	Exact identifier application number: M017
HealthWise Capsaicin Heat Patch	CAPSAICIN	Veridian Healthcare	150c1f09-8aa7-67ea-e063-6294a90a950a	2024-04-01	Warnings	Exact identifier application number: M017
HealthWise Roll-On Lidocaine Pain Relief Liquid Lavender Scent	LIDOCAINE HCI	Veridian Healthcare	150d3e54-5c8d-19ef-e063-6394a90a70c2	2024-04-01	Warnings	Exact identifier application number: M017
Meijer Pain Relief Cream	LIDOCAINE	Meijer Distribution	07ecee44-387a-cdce-e063-6294a90ab9c9	2024-03-27	Warnings	Exact identifier application number: M017
Hydrocortisone Cream	HYDROCORTISONE	Trifecta Pharmaceuticals USA	141aa2a7-8789-1127-e063-6294a90a2d23	2024-03-20	Warnings	Exact identifier application number: M017
Pain Relief Muscle	CAMPHOR (NATURAL)	J.R. Watkins, LLC.	1dc21c95-b419-4175-85f8-040b73060d37	2024-03-20	Warnings	Exact identifier application number: M017
Pain Relief Roll-On Muscle	CAMPHOR (NATURAL)	J.R. Watkins, LLC.	d94ae654-ce25-4bff-b9bd-24a0e0e8568a	2024-03-20	Warnings	Exact identifier application number: M017
Pain Relief Muscle	CAMPHOR (NATURAL)	J.R. Watkins, LLC.	f8bff018-fb4f-47b4-b8f8-4a496aede346	2024-03-20	Warnings	Exact identifier application number: M017
Rugby Arthritis Pain Relieving Topical Analgesic	CAPSAICIN	Rugby Laboratories	8f1bc075-97ac-4154-8768-0d878104c3ba	2024-03-14	Warnings	Exact identifier application number: M017
Rugby Ice Blue External Analgesic	MENTHOL, UNSPECIFIED FORM	Rugby Laboratories	2b65cb6a-4364-4770-b7b9-5c4637edd01a	2024-03-14	Warnings	Exact identifier application number: M017
Leader Cooling Pain Relief Topical Analgesic	MENTHOL, UNSPECIFIED FORM	Cardinal Health, 110 dba LEADER	fd06d17f-4dff-42a9-a84f-904809ceb981	2024-03-13	Warnings	Exact identifier application number: M017
MENTHOL, CAMPHOR	MENTHOL, CAMPHOR	EROS GLOBAL	b3495c95-ba4b-9459-e053-2a95a90a710f	2024-03-12	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE	TRIFECTA PHARMACEUTICALS USA LLC	1369e70f-7a61-7078-e063-6394a90a9a88	2024-03-11	Warnings	Exact identifier application number: M017
Pain Reliever Cream	MENTHOL 10%, METHYL SALICYLATE 15%	Trifecta Pharmaceuticals USA, LLC.	130665d6-3de8-cb91-e063-6294a90a2083	2024-03-06	Warnings	Exact identifier application number: M017
Dermachange Aid Anti-Itch	DIPHENHYDRAMINE HCL	Private Label Beauty and Wellness	12ed906c-d028-0ff7-e063-6394a90aaa52	2024-03-05	Warnings	Exact identifier application number: M017
Dermachange Cold Therapy	MENTHOL	Private Label Beauty and Wellness	12ef7dd8-3da3-9c87-e063-6394a90ac924	2024-03-05	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