FDA.reportPublic FDA data

Levocetirizine Dihydrochloride Tablets USP, 5 mg (OTC)

Manufacturer
Sportpharm LLC
Effective date
2026-02-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:46:11

Label at a glance#

ProductLevocetirizine Dihydrochloride
Active ingredientLEVOCETIRIZINE DIHYDROCHLORIDE
Label structure14 sections

Dosage and administration

 adults 65 years of age and older ask a doctor  adults and children 12 to 64 years of age take 1 tablet (5 mg) once daily in the evening   do not take more than 1 tablet (5 mg) in 24 hours  ½ tablet (2.5 mg) once daily in the evening may be appropriate for less severe symptoms  children 6 to 11 years of age take ½ tablet (2.5 mg) once daily in the evening  do not take more than ½ tablet (2.5 mg) in 24 hours  child...

Label contents#

Full prescribing information#

ACTIVE INGREDIENT(S)

OTC - ACTIVE INGREDIENT SECTION

Levocetirizine dihydrochloride USP 5 mg


PURPOSE

OTC - PURPOSE SECTION

Antihistamine

USE(S)

INDICATIONS & USAGE SECTION

temporarily relieves these symptoms due to hay fever or other respiratory allergies:
• runny nose
• sneezing
• itchy, watery eyes
• itching of the nose or throat


DO NOT USE

OTC - DO NOT USE SECTION

• if you have kidney disease
• if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing cetirizine



ASK A DOCTOR BEFORE USE IF YOU HAVE

OTC - ASK DOCTOR SECTION

  • ever had trouble urinating or emptying your bladder

WHEN USING THIS PRODUCT

OTC - WHEN USING SECTION

  •  drowsiness may occur
  •  avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery

STOP USE AND ASK A DOCTOR IF

OTC - STOP USE SECTION

• you have trouble urinating or emptying your bladder
• an allergic reaction to this product occurs. Seek medical help right away.


IF PREGNANT OR BREAST-FEEDING

OTC - PREGNANCY OR BREAST FEEDING SECTION

  • if breast-feeding: not recommended 
  •  if pregnant: ask a health professional before use

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION


In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

 adults 65 years of age and older
  • ask a doctor
 adults and children 12 to 64 years of age
  • take 1 tablet (5 mg) once daily in the evening  
  • do not take more than 1 tablet (5 mg) in 24 hours 
  • ½ tablet (2.5 mg) once daily in the evening may be appropriate for less severe symptoms
 children 6 to 11 years of age
  • take ½ tablet (2.5 mg) once daily in the evening 
  • do not take more than ½ tablet (2.5 mg) in 24 hours
 children under 6 years of age
  • do not use
 consumers with kidney disease
  • do not use

OTHER INFORMATION

SPL UNCLASSIFIED SECTION

• store between 20° and 25°C (68° and 77°F)
• safety sealed: do not use if carton was opened or if printed foil inner seal on bottle is torn or missing
• safety sealed: do not use if carton was opened or if individual blister unit is open or torn



INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION


colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide.

QUESTIONS or COMMENTS?

SPL UNCLASSIFIED SECTION

call 1-888-588-1418.

Distributed by:

Sportpharm LLC

379 Van Ness Ave 1401,

Torrance, CA 90501

Relabeled by:

Enovachem PHARMACEUTICALS

Torrance, CA 90501

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
855172levocetirizine dihydrochloride 5 MG Oral TabletPSN1
855172levocetirizine dihydrochloride 5 MG Oral TabletSCD1
855172levocetirizine dihydrochloride 5 MG 24 HR Oral TabletSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LEVOCETIRIZINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
36cf9111-9cc4-8f59-a74c-0c1cfbd4a760Product name720190702

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85766-152-35Levocetirizine Dihydrochloride35 in 1 BOTTLETABLET, FILM COATED351
85766-152-35Levocetirizine Dihydrochloride1 in 1 CARTONTABLET, FILM COATED11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69230-321-10EA - Each69230-32184a2a231-d14a-401d-9979-adec87d0ed5312021-01-08
69230-321-31EA - Each69230-32100dec7c6-cc7e-43c1-a75f-a5608954646912021-01-08
69230-321-33EA - Each69230-32133452538-def5-4491-9a09-fab29865059f12021-01-08
69230-321-34EA - Each69230-3212c505c0b-13ca-49dd-a26e-ed381568e57512023-08-08

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85766-15285766-152-35
69230-321

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
MAGNESIUM STEARATE70097M6I30IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
HYPROMELLOSE 2910 (3 MPA.S)0VUT3PMY82IACT
HYPROMELLOSE 2910 (6 MPA.S)0WZ8WG20P6IACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
POLYSORBATE 806OZP39ZG8HIACT
LEVOCETIRIZINE DIHYDROCHLORIDESOD6A38AGAACTIB

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A213513-001LEVOCETIRIZINE DIHYDROCHLORIDELEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-29

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-2984e616aacf4f…
2026-08-18 06:07:402026-07A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-294b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-29782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-2987673890dc5c…
2021-03-12 10:30 UTC2021-03A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-295aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-298869cabd3fbd…
2020-11-12 02:37 UTC2020-11A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-29c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-296a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-291c564ffb4f44…
2023-12-20 04:57 UTC2023-12A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-29ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-29a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-299b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-29a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-293f0d92c62455…
2023-05-13 08:27 UTC2023-05A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-29053a50430f4f…
2023-01-26 05:58 UTC2023-01A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-293bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-293a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-29f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-29e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-29cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213513-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2020-04-29a50c72e98297…

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 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Levocetirizine DihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDESportpharm LLC8c00c74f-4377-4f2c-943e-e55afa5a824f2026-02-14Exact identifier
ndc (package): 85766-152-35
ndc (product): 85766-152
ndc11 (package): 85766015235
spl id: 4ad699ed-f854-f880-e063-6294a90a09bd
spl set id: 8c00c74f-4377-4f2c-943e-e55afa5a824f
Levocetirizine DihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDECamber Consumer Care Incbe72dafb-62ae-40b2-874f-1d8920fad19d2020-11-30Exact identifier
ndc (product): 69230-321

Reported adverse events (FAERS/openFDA)#

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