Hydroxyzine Hydrochloride

Product NDC: 81033-031
11-digit product format: 810330031
Labeler code: 81033
Product ID: 81033-031_4cac7248-0970-077a-e063-6294a90a782d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydroxyzine Hydrochloride
Dosage form: SOLUTION
Route: ORAL
Labeler: Kesin Pharma
Application: ANDA219289
Marketing category: ANDA
Marketing start: 2025-07-17
Substance: HYDROXYZINE DIHYDROCHLORIDE
Active strength: 10 mg/5mL
Pharmacologic classes: Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A219289-001	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA		2025-04-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A219289-001	AA

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A219289-001	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP / ORAL	AA		2025-04-28	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A219289-001	AA	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 24 · 474 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DECONIMO Reconstitution	DECONIMO RECONSTITUTION	Image Amazon LLC	57ab9b1c-9a18-3786-e063-6394a90a2c63	2026-07-28	Warnings	Exact identifier unii: 059QF0KO0R
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	St Mary's Medical Park Pharmacy	9ef6a4b7-362d-61b4-e053-2995a90a0ebb	2026-07-28	Warnings, Adverse reactions	Exact identifier application number: ANDA088617 ndc (package): 60760-285-20 ndc (product): 60760-285 spl id: 57ae485e-ca4b-92da-e063-6294a90af11a spl set id: 9ef6a4b7-362d-61b4-e053-2995a90a0ebb unii: 76755771U3
HydrOXYzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	A-S Medication Solutions	5dea636d-dee6-47d4-b83c-b9f0c0b1b6ca	2026-07-24	Warnings, Adverse reactions	Exact identifier application number: ANDA040840 ndc (package): 50090-6682-5 ndc (package): 50090-6682-3 ndc (package): 50090-6682-0 ndc (product): 50090-6682 spl id: 4c40489b-3c42-43ca-b0ab-033ee3083f56 spl set id: 5dea636d-dee6-47d4-b83c-b9f0c0b1b6ca unii: 76755771U3
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	30b6f7b3-b620-961a-e063-6394a90a487b	2026-07-23	Warnings, Adverse reactions	Exact identifier application number: ANDA217652 ndc (package): 60760-990-30 ndc (product): 60760-990 rxcui: 995258 spl id: 5747da5b-deeb-5ad6-e063-6394a90af2f5 spl set id: 30b6f7b3-b620-961a-e063-6394a90a487b unii: 76755771U3
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	REMEDYREPACK INC.	ca67c061-c743-4ebb-a9d5-ece488060663	2026-07-22	Warnings, Adverse reactions	Exact identifier application number: ANDA088618 ndc (package): 70518-2279-0 ndc (package): 70518-2279-2 ndc (package): 70518-2279-1 ndc (package): 70518-2279-3 ndc (product): 70518-2279 rxcui: 995258 spl id: 57342f6a-9730-3aaf-e063-6294a90a44b5 spl set id: ca67c061-c743-4ebb-a9d5-ece488060663 unii: 76755771U3
Xenleta	LEFAMULIN ACETATE	Meitheal Pharmaceuticals Inc.	eb972ea8-7502-422e-84bb-66cb8e93ca06	2026-07-22	Warnings, Adverse reactions	Exact identifier unii: XF417D3PSL
Sterile Water	WATER	Cardinal Health 107, LLC	9655cd02-82b5-4a75-813b-854b19551481	2026-07-21	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	APOZEAL PHARMACEUTICALS INC	87d4bbff-0498-4c26-86cb-7ce173afa0b6	2026-07-21	Warnings, Adverse reactions	Exact identifier application number: ANDA210634 ndc (package): 83745-232-16 ndc (product): 83745-232 rxcui: 995241 spl id: 81d956c2-b9db-4f60-9d66-5ca552942e59 spl set id: 87d4bbff-0498-4c26-86cb-7ce173afa0b6 unii: 76755771U3
HydrOXYzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	A-S Medication Solutions	be6a2f09-c0f3-44e2-aac3-37e3702b93f0	2026-07-21	Warnings, Adverse reactions	Exact identifier application number: ANDA040840 ndc (package): 50090-2614-3 ndc (package): 50090-2614-1 ndc (package): 50090-2614-4 ndc (package): 50090-2614-0 ndc (product): 50090-2614 rxcui: 995281 spl id: 9170c6ac-11fc-4d1d-b80d-a918895492cd spl set id: be6a2f09-c0f3-44e2-aac3-37e3702b93f0 unii: 76755771U3
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	Cardinal Health 107, LLC	b4d274ce-d616-4835-80ce-76270524ed36	2026-07-20	Warnings, Adverse reactions	Exact identifier application number: ANDA088618 ndc (package): 55154-2148-0 ndc (product): 55154-2148 rxcui: 995258 spl id: 1990038a-5c92-4ccf-8b76-b0da11e5031e spl set id: b4d274ce-d616-4835-80ce-76270524ed36 unii: 76755771U3
Hydroxyzine hydrochloride	HYDROXYZINE HYDROCHLORIDE	Major Pharmaceuticals	7f76580c-96a0-4b56-8986-ff5488bb9869	2026-07-15	Warnings, Adverse reactions	Exact identifier application number: ANDA204279 ndc (package): 0904-7378-40 ndc (package): 0904-7377-80 ndc (package): 0904-7379-40 ndc (package): 0904-7377-40 ndc (package): 0904-7379-80 ndc (package): 0904-7378-80 ndc (product): 0904-7379 ndc (product): 0904-7377 ndc (product): 0904-7378 rxcui: 995218 rxcui: 995281 rxcui: 995258 spl id: 4a711adb-4df8-48f2-bac2-90a4ad3641af spl set id: 7f76580c-96a0-4b56-8986-ff5488bb9869 unii: 76755771U3
Hydroxyzine hydrochloride	HYDROXYZINE HYDROCHLORIDE	REMEDYREPACK INC.	bb4a7d22-2f42-4e9f-bf98-cee43ed14d50	2026-07-15	Warnings, Adverse reactions	Exact identifier application number: ANDA204279 ndc (package): 70518-0487-1 ndc (package): 70518-0487-0 ndc (product): 70518-0487 rxcui: 995281 spl id: 56a67111-724a-49aa-e063-6294a90a0cb6 spl set id: bb4a7d22-2f42-4e9f-bf98-cee43ed14d50 unii: 76755771U3
Hydroxyzine hydrochloride	HYDROXYZINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc	c8b441bf-a03e-47b3-8f06-c347f5ca4b70	2026-07-15	Warnings, Adverse reactions	Exact identifier application number: ANDA204279 ndc (package): 68788-4150-3 ndc (product): 68788-4150 rxcui: 995218 spl id: c8b441bf-a03e-47b3-8f06-c347f5ca4b70 spl set id: c8b441bf-a03e-47b3-8f06-c347f5ca4b70 unii: 76755771U3
Hydroxyzine hydrochloride	HYDROXYZINE HYDROCHLORIDE	REMEDYREPACK INC.	b6189074-e199-4f58-a78d-c04f131c13d9	2026-07-10	Warnings, Adverse reactions	Exact identifier application number: ANDA204279 ndc (package): 70518-1692-0 ndc (package): 70518-1692-2 ndc (package): 70518-1692-1 ndc (product): 70518-1692 rxcui: 995258 spl id: 5640f1bb-bd8a-2b9a-e063-6294a90a1640 spl set id: b6189074-e199-4f58-a78d-c04f131c13d9 unii: 76755771U3
Hydroxyzine Hydrochloride	HYDROXYZINE HYDROCHLORIDE	REMEDYREPACK INC.	aa9523e0-c95d-4213-b213-96170d855536	2026-07-10	Warnings, Adverse reactions	Exact identifier application number: ANDA040787 ndc (package): 70518-1730-7 ndc (package): 70518-1730-1 ndc (package): 70518-1730-0 ndc (package): 70518-1730-4 ndc (package): 70518-1730-6 ndc (package): 70518-1730-2 ndc (package): 70518-1730-5 ndc (package): 70518-1730-3 ndc (product): 70518-1730 rxcui: 995258 spl id: 56434227-f321-056c-e063-6294a90a7a0a spl set id: aa9523e0-c95d-4213-b213-96170d855536 unii: 76755771U3
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	Advanced Rx of Tennessee, LLC	5648abce-f20e-717c-e063-6294a90a88ac	2026-07-10	Warnings, Adverse reactions	Exact identifier application number: ANDA217652 ndc (package): 80425-0590-3 ndc (package): 80425-0590-2 ndc (package): 80425-0590-1 ndc (product): 80425-0590 rxcui: 995258 spl id: 5648abd7-f01a-43fb-e063-6294a90ab817 spl set id: 5648abce-f20e-717c-e063-6294a90a88ac unii: 76755771U3
Dr. Drop NMN Vital Balance (Drop No.1 Cream 90g)	NMN (NICOTINAMIDE MONONUCLEOTIDE), ECTOIN (ECTOINE)	Reedfresh Co., LTD	55d703ca-ff9d-0dbc-e063-6294a90ab6b1	2026-07-05	Warnings	Exact identifier unii: 059QF0KO0R
Eyesaline Eyewash Concentrate	PURIFIED WATER	Protective Industrial Products, Inc.	558e5926-9027-d3f6-e063-6294a90ab121	2026-07-02	Warnings	Exact identifier unii: 059QF0KO0R
Fendall 2000 Pure Flow	PURIFIED WATER	Protective Industrial Products, Inc.	55a1d07e-0006-0c75-e063-6394a90a7acc	2026-07-02	Warnings	Exact identifier unii: 059QF0KO0R
Fendall 1000 Pure Flow	PURIFIED WATER	Protective Industrial Products, Inc.	55a2f4da-bb1e-8ead-e063-6394a90af72e	2026-07-02	Warnings	Exact identifier unii: 059QF0KO0R

Additional Listing Data#

Finished product: Yes
Brand name base: Hydroxyzine Hydrochloride
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HYDROXYZINE DIHYDROCHLORIDE	10 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
76755771U3	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
995241	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
4b094d1b-97b2-6ca6-e063-6294a90a2437	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
57311cfb-679a-da1a-b70c-8757f7fc431a	Product name	4	20250516
aa1826f4-97c1-4705-bdf0-3bc7d234e618	Product name	2	20190618
75cb12ee-8eb2-4f1a-a332-5743a5d0da41	Product name	1	20151110
3ca5f78b-43dc-30fe-8014-55b922af52b3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
81033-031-05	Hydroxyzine Hydrochloride	5 mL in 1 CUP, UNIT-DOSE	SOLUTION	5	2
81033-031-12	Hydroxyzine Hydrochloride	12.5 mL in 1 CUP, UNIT-DOSE	SOLUTION	12.5	2
81033-031-44	Hydroxyzine Hydrochloride	40 in 1 CARTON	SOLUTION	40	2
81033-031-45	Hydroxyzine Hydrochloride	40 in 1 CARTON	SOLUTION	40	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
81033-031-05	ML - Milliliter	81033-031	d792c426-65f3-4a59-bc7c-da089105f7be	1	2026-04-20
81033-031-12	ML - Milliliter	81033-031	d75e6d7f-abba-4225-9f70-bb18b58d6ea3	1	2026-04-20
81033-031-44	ML - Milliliter	81033-031	c0a022c7-f081-46f7-81ce-460abec27ed9	1	2026-04-20
81033-031-45	ML - Milliliter	81033-031	1f586e30-cc21-4d11-91f3-2897b6cb3418	1	2026-04-20

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
76755771U3	HYDROXYZINE HYDROCHLORIDE	2192-20-3	Hydroxyzine Hydrochloride

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
995241	hydrOXYzine HCl 10 MG in 5 mL Oral Solution	PSN	4b094d1b-97b2-6ca6-e063-6294a90a2437	2
995241	hydroxyzine hydrochloride 2 MG/ML Oral Solution	SCD	4b094d1b-97b2-6ca6-e063-6294a90a2437	2
995241	hydroxyzine hydrochloride 10 MG per 5 ML Oral Solution	SY	4b094d1b-97b2-6ca6-e063-6294a90a2437	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
81033-031-05	81033003105	5 mL in 1 CUP, UNIT-DOSE	5 ml				Historical
81033-031-12	81033003112	12.5 mL in 1 CUP, UNIT-DOSE	12.5 ml				Historical
81033-031-44	81033003144	40 CUP, UNIT-DOSE in 1 CARTON (81033-031-44) / 5 mL in 1 CUP, UNIT-DOSE (81033-031-05)		2026-02-27	No	No	Current
81033-031-45	81033003145	40 CUP, UNIT-DOSE in 1 CARTON (81033-031-45) / 12.5 mL in 1 CUP, UNIT-DOSE (81033-031-12)		2026-02-27	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
hydrOXYzine Hydrochloride Oral Solution, USP (Syrup) Rx only	Kesin Pharma	2026-03-10	HUMAN PRESCRIPTION DRUG LABEL	2