NDC 5011-308 - Hydroxyzine Hydrochloride

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 5011-308
Manufacturer: RedPharm Drug Inc. | Pliva Inc.
Effective date: 2011-07-14
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
HYDROXYZINE HYDROCHLORIDE TABLETS USP	RedPharm Drug Inc. \| Pliva Inc.	2011-07-14	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HYDROXYZINE HYDROCHLORIDE	ACTIVE INGREDIENT	76755771U3	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REDPHARM DRUG INC.]	1
HYDROXYZINE	ACTIVE MOIETY	30S50YM8OG	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REDPHARM DRUG INC.]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REDPHARM DRUG INC.]	1
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REDPHARM DRUG INC.]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REDPHARM DRUG INC.]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REDPHARM DRUG INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REDPHARM DRUG INC.]	1
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REDPHARM DRUG INC.]	1
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REDPHARM DRUG INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REDPHARM DRUG INC.]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REDPHARM DRUG INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REDPHARM DRUG INC.]	1
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REDPHARM DRUG INC.]	1

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 37 of 137 · 2,730 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 1.5N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	08b0e056-583a-474b-aaaa-ecea05703044	2025-12-19	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 2.5W	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	a89af40e-cf45-4afc-aac7-5f71a05bcd3f	2025-12-19	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 2.5N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	6da72e20-f2d7-492e-9b65-b5ac73bc0029	2025-12-19	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 1CR	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	de615c3e-669f-493c-9c75-73dfbe726c59	2025-12-19	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 1N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	152790ba-aeda-4c2a-b725-7e040e832883	2025-12-19	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 1.5W	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	5f5cd18a-04fa-4b53-b7e9-6b1e97acc61a	2025-12-19	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 0W	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	54f7fe8d-aab4-4fab-b239-52c5e7ce7c0c	2025-12-19	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 0N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	c87e5201-f7fd-4fd9-adeb-d6af9be00db6	2025-12-19	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 0CR	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	84cdaad2-5b7d-4841-bef6-ffad4fe6907a	2025-12-19	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 00	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	b4caa2bc-8118-4137-8834-25800f8e5e01	2025-12-19	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 0.5N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	c0fa32fe-faa7-4a47-906c-14db01e55d47	2025-12-19	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 8N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	ff1a8b32-c01f-4910-9a7a-c74eb49c05a0	2025-12-19	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 7N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	d3bd710b-7d1a-4f96-9fbc-a67c550d863b	2025-12-19	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 7W	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	3b6ea0ec-4636-43cf-a324-a82666108e95	2025-12-19	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 7.5N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	5ac7fb96-a2f2-4086-82ad-c45d7a709091	2025-12-19	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 6W	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	84a5f7e1-1c04-43cd-8d3b-60c7e2418faf	2025-12-19	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 6N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	28a61b11-5901-47ec-916c-e2ae4f79a11d	2025-12-19	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 6.5W	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	5ddf8221-9bfc-4c52-9a51-a0d725b7a23e	2025-12-19	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 6.5N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	5937248a-b96e-490a-9f93-10e65969ac10	2025-12-19	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 5W	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	2cc7d9f6-f789-4f9b-91b7-73f9d0fee85c	2025-12-19	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.