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 24 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
A Health Itch Relief Gel	ITCH RELIEF GEL	Pharma Nobis, LLC	4f80c403-c760-31ec-e063-6394a90a61c9	2026-04-15	Warnings	Exact identifier application number: M017
Family Care Antibiotic Pain Relief 0.33oz	ANTIBIOTIC PAIN RELIEF	United Exchange Corp	4f8405fc-3e38-05d9-e063-6394a90a4cda	2026-04-15	Warnings	Exact identifier application number: M017
BiteMD	INSECT BITE RELIEF	Wisconsin Pharmacal Company	4f860c1e-a638-4923-e063-6294a90ae7e2	2026-04-15	Warnings	Exact identifier application number: M017
LavaDerm AfterSun	MENTHOL	Young Living Essential Oils, LC.	4fcddcf1-36db-2f1a-e054-00144ff8d46c	2026-04-15	Warnings	Exact identifier application number: M017
Arlun Numbing Cream	NUMBING CREAM	Guangzhou Jingliang Cosmetics Co., Ltd.	4f8b60f9-03e3-e731-e063-6294a90a3b0a	2026-04-15	Warnings	Exact identifier application number: M017
tuiwaro Numbing Cream	NUMBING CREAM	Guangzhou Jingliang Cosmetics Co., Ltd.	4f66178c-95d9-8c6a-e063-6294a90a2c09	2026-04-14	Warnings	Exact identifier application number: M017
Lidocaine Pain Relief Roll-On	LIDOCAINE 4%	Pharma Nobis, LLC	4f6d9a51-c42e-ca88-e063-6394a90a8659	2026-04-14	Warnings	Exact identifier application number: M017
Hot/Cold Menthol 16% Roll-On	HOT/COLD MENTHOL 16% ROLL-ON	Pharma Nobis, LLC	4f6f5a0b-3bfa-289e-e063-6294a90a94b3	2026-04-14	Warnings	Exact identifier application number: M017
Sting Relief Swab	BENZOCAINE	4 Visions LLC	4f76a8c5-fde6-eee0-e063-6394a90a09f8	2026-04-14	Warnings	Exact identifier application number: M017
Signature Pain Relief Cream	4% LIDOCAINE	Shengnan (Guangzhou) Cosmetics Co., LTD	4f555b8f-5193-e685-e063-6294a90a7ba2	2026-04-13	Warnings	Exact identifier application number: M017
Deep Numbing Cream	MENTHOL	YITONGBADA (SHENZHEN) INTERNATIONAL TRADE CO., LTD	7943559b-de10-4214-96dc-f9cbac828f46	2026-04-13	Warnings	Exact identifier application number: M017
Hydrocortisone Cream 1%	HYDROCORTISONE CREAM 1% WITH ALOE	Publix Super Markets Inc.	3c45a654-7fec-55b3-e063-6294a90a184b	2026-04-13	Warnings	Exact identifier application number: M017
Hydrocortisone with Aloe	HYDROCORTISONE CREAM 1%	AMERISOURCE BERGEN	4f5aea1c-ae51-4e1a-e063-6294a90a6aa1	2026-04-13	Warnings	Exact identifier application number: M017
ActivICE	MENTHOL	Medline Industries, LP	8465b443-abe9-78fb-e053-2a91aa0ac1d8	2026-04-13	Warnings	Exact identifier application number: M017
4Jointz	MENTHOL	ARP(USA) Pty Ltd	94a5b5f5-abf7-40b3-9dd7-43e2c22f138e	2026-04-13	Warnings	Exact identifier application number: M017
Sumifun Pain Relief Creams	METHYL SALICLATE CAPSAICIN CAMPHOR	Guchutang Biotechnology (Longyan) Co., Ltd	4f3dd96a-d843-d810-e063-6394a90a188e	2026-04-12	Warnings	Exact identifier application number: M017
BonicaEaseX 24 Hour Menthol Pain Relieving	MENTHOL, UNSPECIFIED FORM	Planet (Anhui) Pharmaceutical Co., Ltd.	17fc0cd1-710d-45e6-9513-d7100e3adb42	2026-04-10	Warnings	Exact identifier application number: M017
BonicaEaseX Colorless Roll-On Menthol Pain Relieving	MENTHOL, UNSPECIFIED FORM	Planet (Anhui) Pharmaceutical Co.,Ltd	acf460b4-1b41-4b30-a74a-6c3613119d8e	2026-04-10	Warnings	Exact identifier application number: M017
BonicaEaseX Menthol Pain Relieving	MENTHOL, UNSPECIFIED FORM	Planet (Anhui) Pharmaceutical Co.,Ltd	4d84b4fb-8f55-4b2b-b261-858edb7f3144	2026-04-10	Warnings	Exact identifier application number: M017
HealthWise Pain Relief Gel Patch	CAPSAICIN, MENTHOL	Veridian Healthcare	f5484151-b6da-4f64-867f-87160a4ec2d6	2026-04-10	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