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 137 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Burn First Aid	BURN FIRST AID	Dynarex Corporation	826e08be-dffa-5a27-e053-2a91aa0a8701	2024-01-22	Warnings	Exact identifier application number: M017
Target Up and Up Pain Relief Menthol Topical Analgesic Roll-On	MENTHOL	TARGET CORPORATION	0f95fc55-8665-9e89-e063-6394a90a7891	2024-01-22	Warnings	Exact identifier application number: M017
CVS Health Lidocaine Pain Relief Plus Menthol	LIDOCAINE, MENTHOL, UNSPECIFIED FORM	Natural Essentials, Inc.	77978069-a1b4-473e-83c9-8320e00eea89	2024-01-19	Warnings	Exact identifier application number: M017
ZIMS MAX FREEZE LEG CRAMPS	CAMPHOR, MENTHOL	KOBAYASHI Healthcare International, Inc.	ba26635d-95d3-4d88-93cc-1fd4fd29fd79	2024-01-18	Warnings	Exact identifier application number: M017
Burn	LIDOCAINE	HART Health	e95ebdac-9789-41c2-97da-2307e4538794	2024-01-18	Warnings	Exact identifier application number: M017
Medi-First Hydrocortisone 1%	HYDROCORTISONE ACETATE	Unifirst First Aid Corporation	bd216f5d-f304-7d8d-e053-2a95a90aa9ce	2024-01-17	Warnings	Exact identifier application number: M017
Green Guard Hydrocortisone 1%	HYDROCORTISONE	Unifirst First Aid Corporation	bd348e2a-57b1-3f17-e053-2a95a90a8bdc	2024-01-17	Warnings	Exact identifier application number: M017
Pain Relief	LIDOCAINE, MENTHOL	HUMN Pharmaceuticals Inc	6c96f94a-e724-eab3-e053-2991aa0aab88	2024-01-17	Warnings	Exact identifier application number: M017
CVS Health Lidocaine Pain Relief	LIDOCAINE	Natural Essentials, Inc.	52e82e70-53b7-4ecb-be39-fe10c94cc444	2024-01-17	Warnings	Exact identifier application number: M017
CVS Health XL Lidocaine Pain Relief	LIDOCAINE	NATURAL ESSENTIALS, INC.	ec16da91-8244-402b-b8d8-84896094ac2c	2024-01-17	Warnings	Exact identifier application number: M017
Anti-itch	DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE	Target Corporation	f444b0a6-2ed3-4236-8206-342150290675	2024-01-17	Warnings	Exact identifier application number: M017
Maximum Strength Hydrocortisone Anti-itch	HYDROCORTISONE 1%	Target Corporation	4ff39cb8-3a20-4fe7-9829-1e882a484668	2024-01-17	Warnings	Exact identifier application number: M017
Burn	LIDOCAINE HYDROCHLORIDE	Nantong Health & Beyond Hygienic Products Inc.	eca272cb-ac8f-982b-e053-2995a90aa8b2	2024-01-15	Warnings	Exact identifier application number: M017
American Safety and First Aid	HYDROCORTISONE ACETATE	Orazen Inc	eb0cfde0-c463-e9b5-e053-2a95a90a1924	2024-01-15	Warnings	Exact identifier application number: M017
American Safety and First Aid	HYDROCORTISONE ACETATE	Orazen Inc	eb0cce4b-c70a-1b2d-e053-2995a90aa4aa	2024-01-15	Warnings	Exact identifier application number: M017
Oral Pain Relief Gel	BENZOCAINE 20%	Sled Distribution, LLC	e7391302-831e-14dc-e053-2a95a90ac236	2024-01-15	Warnings	Exact identifier application number: M017
FIRST SHIELD	LIDOCAINE HCI	Ever Ready First Aid	e022bf8f-3dd8-de22-e053-2995a90a219b	2024-01-15	Warnings	Exact identifier application number: M017
Flexigen	MENTHOL 1.25%	Derma Care Research Labs, LLC	e9ae2682-59b4-e796-e053-2995a90af921	2024-01-15	Warnings	Exact identifier application number: M017
Vita-P Oral and Nasal	MENTHOL 1%	Beijing HKKY Medical Tech. Co., Ltd.	537c3843-1c92-41c6-b724-52701bbddeab	2024-01-13	Warnings	Exact identifier application number: M017
Caring mill Lidocaine Aloe Gel Burn and Pain Relief	LIDOCAINE HYDROCHLORIDE	FSA Store Inc.	0ec20c87-1681-dd23-e063-6394a90a291c	2024-01-12	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