Aveeno Anti-Itch Concentrated

Product NDC: 69968-0475
Requested package NDC: 69968-0475-4
11-digit product format: 699680475
Labeler code: 69968
Product ID: 69968-0475_4231d5a3-ee70-83e1-e063-6294a90a0c9b
Type: HUMAN OTC DRUG
Nonproprietary name: Zinc Oxide, Ferric Oxide Red, and Pramoxine Hydrochloride
Dosage form: LOTION
Route: TOPICAL
Labeler: Kenvue Brands LLC
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2019-03-01
Substance: ZINC OXIDE; FERRIC OXIDE RED; PRAMOXINE HYDROCHLORIDE
Active strength: 29.4; .6; 10 mg/mL; mg/mL; mg/mL
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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: Aveeno Anti-Itch Concentrated
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ZINC OXIDE	29.4 mg/mL
FERRIC OXIDE RED	.6 mg/mL
PRAMOXINE HYDROCHLORIDE	10 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
SOI2LOH54Z	Internal UNII lookup
1K09F3G675	Internal UNII lookup
88AYB867L5	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1233698	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
07f4d4d0-9cee-46c3-bc71-2024abd31c9e	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
a7051cba-790b-a699-81f8-dbbbdbd9b5ac	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
da108d9e-edc8-17a3-8c28-3251c6a8accc	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69968-0475-4	Aveeno Anti-Itch Concentrated	118 mL in 1 BOTTLE	LOTION	118		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69968-0475	AVEENO ANTI-ITCH CONCENTRATED (ZINC OXIDE, FERRIC OXIDE RED, AND PRAMOXINE HYDROCHLORIDE) LOTION [KENVUE BRANDS LLC]	5	Current NDC, Legacy NDC, 1 package rows	20241107_07f4d4d0-9cee-46c3-bc71-2024abd31c9e.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 102 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
K19 RELIEF	MENTHOL	K19 LLC	e2e1ca96-1ae8-4c99-b8de-ce26754292f9	2025-01-15	Warnings	Exact identifier application number: M017
Anecream	LIDOCAINE 4%	Focus Health Group	2d7706e2-7363-4047-96cb-85b718277e8c	2025-01-15	Warnings	Exact identifier application number: M017
Boroleum	CAMPHOR, MENTHOL, WHITE PETROLATUM	Reliable 1 Laboratories	846568af-0fdd-a80e-e053-2a91aa0a9c9e	2025-01-15	Warnings	Exact identifier application number: M017
LidoPro Pain Relief	CAPSAICIN AND LIDOCAINE	Advanced Rx of Tennessee, LLC	27d5997b-1cc2-41c2-e063-6394a90ac74a	2025-01-15	Warnings	Exact identifier application number: M017
Pain Relief Patch 4% Lidocaine	LIDOCAINE	Reliable 1 Laboratories LLC	2b624763-c310-63d9-e063-6394a90a1928	2025-01-15	Warnings	Exact identifier application number: M017
Cannarelief 1000mg	MENTHOL	Carolina Cannabis Creations LLC	01e2ae1a-c969-6dd2-e063-6394a90a9d9e	2025-01-15	Warnings	Exact identifier application number: M017
Healing Hand Cream 2000mg	MENTHOL	Carolina Cannabis Creations LLC	01f8795b-9f95-c793-e063-6394a90a8330	2025-01-15	Warnings	Exact identifier application number: M017
CBD Clinic Deep-Rub Pain Relief - Level 5	CAMPHOR, MENTHOL	ABACUS HEALTH PRODUCTS, INC.	31e2e5cd-d33e-f058-e063-6394a90af7d2	2025-01-14	Warnings	Exact identifier application number: M017
Meijer Odor Free Analgesic Pain Relieving Topical Analgesic	LIDOCAINE HYDROCHLORIDE	Meijer Distribution, Inc	6288efea-f636-4eea-bb9f-78aa2f9af54a	2025-01-14	Warnings	Exact identifier application number: M017
IKONIK TONIK	LIDOCAINE HYDROCHLORIDE	IKONIK CARE, LLC	122fdfe8-b5fa-46d1-9fd9-3df9887ed320	2025-01-14	Warnings	Exact identifier application number: M017
elp essential MANTECA DE UBRE	METHYL SALICYLATE, CAMPHOR	Miramar Cosmetics, Inc DBA Miramar Lab	c3964dfe-17fe-4d89-a4c4-cf500f982259	2025-01-13	Warnings	Exact identifier application number: M017
Methylten	METHYL SALICYLATE 10%	Puretek Corporation	28f4093f-803f-0e70-e063-6294a90a98a4	2025-01-13	Warnings	Exact identifier application number: M017
Refill Bundle 7 Large Office	BENZALKONIUM CHLORIDE	CMC Group, Inc.	6620a8f3-098d-d045-e053-2a91aa0a0d94	2025-01-13	Warnings	Exact identifier application number: M017
Jakwork Numbing Cream	NUMBING CREAM	Guangzhou Zanming Trading Co., Ltd.	2ba1de83-494a-6c54-e063-6294a90a9b2d	2025-01-13	Warnings	Exact identifier application number: M017
Arthritis Hot	MENTHOL AND METHYL SALICYLATE	Chattem, Inc.	cc57b9b6-8ba5-4ff3-a5df-97d8f5b1bebd	2025-01-13	Warnings	Exact identifier application number: M017
Re-Lieved Lidocaine Patch	LIDOCAINE PATCH 4%	Transfer Technology	00b40dda-53ad-0458-e063-6394a90aa835	2025-01-11	Warnings	Exact identifier application number: M017
Re-Lieved Lidocaine Patch	LIDOCAINE PATCH 4%	Transfer Technology	00b47eb7-6b43-d9e2-e063-6294a90a9a38	2025-01-11	Warnings	Exact identifier application number: M017
Re-Lieved 4% Lidocaine Fabric Tape	LIDOCAINE 4% FABRIC TAPE	Transfer Technology	e9a894b0-54f2-707e-e053-2a95a90a0f0d	2025-01-11	Warnings	Exact identifier application number: M017
Re-Lieved 3 in 1 Patch	MENTHOL, CAMPHOR, METHYL SALICYLATE PATCH	Transfer Technology	e9ab9a03-b9e3-7317-e053-2995a90a9950	2025-01-11	Warnings	Exact identifier application number: M017
ASTRAPHARM CHILLI BRAND	CAPSAICIN	Dersan Pharmaceutical Co., Ltd	b4c2d4fd-7d5d-4156-ac27-e72ebc9671ec	2025-01-10	Warnings	Exact identifier application number: M017

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE
1K09F3G675	FERRIC OXIDE RED	1309-37-1	FERRIC OXIDE RED
88AYB867L5	PRAMOXINE HYDROCHLORIDE	637-58-1	PRAMOXINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1233698	calamine 3 % / pramoxine HCl 1 % Topical Lotion	PSN	07f4d4d0-9cee-46c3-bc71-2024abd31c9e	6
1233698	calamine 30 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Lotion	SCD	07f4d4d0-9cee-46c3-bc71-2024abd31c9e	6
1233698	calamine 3 % / pramoxine hydrochloride 1 % Topical Lotion	SY	07f4d4d0-9cee-46c3-bc71-2024abd31c9e	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69968-0475-4	69968047504	118 mL in 1 BOTTLE (69968-0475-4)	118 ml	2019-03-01	0000-00-00	No	No	Current