LEVONORGESTREL

Manufacturer
H.J. Harkins Company, Inc.
Effective date
2019-09-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:00:35

Label at a glance#

ProductLEVONORGESTREL
Active ingredientLEVONORGESTREL
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Levonorgestrel USP 1.5 mg

OTC - PURPOSE SECTION

Emergency contraceptive

INDICATIONS & USAGE SECTION

Use for women to reduce chance of pregnancy after unprotected sex (if a contraceptive failed or if you did not use birth control).

WARNINGS SECTION

Allergy alert: Do not use if you have ever had an allergic reaction to levonorgestrel.

Sexually transmitted diseases (STDs) alert: This product does not protect against HIV/AIDS or other STDs

Do not use

if you are already pregnant (because it will not work)
for regular birth control

Ask a doctor or pharmacist before use if you are taking efavirenz (HIV medication) or rifampin (tuberculosis treatment) or medication for seizures (epilepsy). These medications may reduce the effectiveness of levonorgestrel.

When using this product you may have

menstrual changes
nausea
lower stomach (abdominal) pain
tiredness
headache
dizziness
breast pain
vomiting

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children.

In case of overdose, get medical help or contact a Poison Control center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

take as soon as possible within 72 hours (3 days) after unprotected sex. The sooner you take it the better it will work.
if you vomit within 2 hours after taking the medication, call a healthcare professional to find out if you should repeat the dose.

Other Information

read the instructions, warnings and enclosed product leaflet before use .
this product works mainly by preventing ovulation (egg release). It may also prevent fertilization of a released egg (joining of sperm and egg) or attachment of a fertilized egg to the uterus (implantation).
Do not use if carton is open or blister seal is broken or missing .
store at 25°C (77°C); excursions permitted to 15 to 30°C (59 to 86°C) [see USP Controlled Room temperature].

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, and povidone.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
483325levonorgestrel 1.5 MG Oral TabletPSN1
483325levonorgestrel 1.5 MG Oral TabletSCD1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LEVONORGESTREL Pharmacologic Class Indexing3Indexing - Pharmacologic Class20230718

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8511fc19-172b-4e1f-90ec-2f09c85b16deProduct name220250116
a0f93f28-4e91-4bb1-8dcb-5456fd4bfc50Product name320230718
fa479cfe-0bd0-7366-d57a-92f3682e87c5Product name320210518
20e1a411-dba8-4afa-b9f9-1205d5b0bde9Product name320210513
5956a0e2-c373-452c-bdcf-c93d354432efProduct name120200714
ca306105-d51c-4821-9ec1-8eec753d073dProduct name120200619
d2c4820a-bb24-f61d-8cd0-dd0290a6bd4dProduct name720190612
f92411e4-13dd-7baf-106e-9b3fcf758c39Product name420190502
f713a022-3e1c-4035-bc91-62131bc80b42Product name220190125
79d5025d-8129-440a-b861-6df2d2661609Product name320180607
d871c48c-6b0b-4203-b55d-72ead21ea7adProduct name520180419
12434b90-2738-45d5-9e1b-55001e853273Product name220171122
741e98f2-ac6c-4d80-9ca8-c663c171ba1dProduct name120161121
cc765024-f257-4c67-b780-c356aadd6980Product name320150902
5a9b579b-8431-5b3a-2ba4-86556704f873Product name120140508
5f44c957-835a-ada0-662f-5b1071b7a68bProduct name120140508
d03a75af-b11b-673b-268b-318050d0b3bdProduct name120140508
d0cc7d42-77a7-b452-c6c3-a162fa11225fProduct name120140508
e5ccd419-1745-560a-1e25-c6e3941c710aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76519-1164-02022-01-28C16284748780-1d6a99b39-84fb-a426-e053-dadaa90af4c21164 LEVONORGESTREL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76519-1164-0LEVONORGESTREL1 in 1 BOXTABLET11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76519-1164LEVONORGESTREL TABLET [H.J. HARKINS COMPANY, INC.]1Legacy NDC, 1 package rows20190926_92dcd064-5d9f-29b6-e053-2a95a90a1bf1.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76519-116476519-1164-0

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

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
A201446-001FALLBACK SOLOLEVONORGESTREL1.5MGTABLET / ORAL2014-06-19

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.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A201446-001FALLBACK SOLO1.5MGTABLET / ORAL2014-06-1984e616aacf4f…
2026-08-18 06:07:402026-07A201446-001FALLBACK SOLO1.5MGTABLET / ORAL2014-06-19caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A201446-001FALLBACK SOLO1.5MGTABLET / ORAL2014-06-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201446-001FALLBACK SOLO1.5MGTABLET / ORAL2014-06-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A201446-001FALLBACK SOLO1.5MGTABLET / ORAL2014-06-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201446-001FALLBACK SOLO1.5MGTABLET / ORAL2014-06-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201446-001FALLBACK SOLO1.5MGTABLET / ORAL2014-06-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201446-001FALLBACK SOLO1.5MGTABLET / ORAL2014-06-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201446-001FALLBACK SOLO1.5MGTABLET / ORAL2014-06-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201446-001FALLBACK SOLO1.5MGTABLET / ORAL2014-06-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201446-001FALLBACK SOLO1.5MGTABLET / ORAL2014-06-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A201446-001FALLBACK SOLO1.5MGTABLET / ORAL2014-06-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201446-001FALLBACK SOLO1.5MGTABLET / ORAL2014-06-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201446-001FALLBACK SOLO1.5MGTABLET / ORAL2014-06-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201446-001FALLBACK SOLO1.5MGTABLET / ORAL2014-06-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05A201446-001FALLBACK SOLO1.5MGTABLET / ORAL2014-06-198072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201446-001FALLBACK SOLO1.5MGTABLET / ORAL2014-06-195c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A201446-001FALLBACK SOLO1.5MGTABLET / ORAL2014-06-195d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A201446-001FALLBACK SOLO1.5MGTABLET / ORAL2014-06-194b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A201446-001FALLBACK SOLO1.5MGTABLET / ORAL2014-06-1974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A201446-001FALLBACK SOLO1.5MGTABLET / ORAL2014-06-19bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A201446-001FALLBACK SOLO1.5MGTABLET / ORAL2014-06-19782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A201446-001FALLBACK SOLO1.5MGTABLET / ORAL2014-06-1987673890dc5c…
2021-03-12 10:30 UTC2021-03A201446-001FALLBACK SOLO1.5MGTABLET / ORAL2014-06-195aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A201446-001FALLBACK SOLO1.5MGTABLET / ORAL2014-06-198869cabd3fbd…
2020-11-12 02:37 UTC2020-11A201446-001FALLBACK SOLO1.5MGTABLET / ORAL2014-06-19c0c555d07b60…
2019-12-14 00:12 UTC2019-12A201446-001FALLBACK SOLO1.5MGTABLET / ORAL2014-06-193f01610625f2…
2019-09-15 20:21 UTC2019-09A201446-001FALLBACK SOLO1.5MGTABLET / ORAL2014-06-19b00525d2431f…
2019-07-19 19:46 UTC2019-07A201446-001FALLBACK SOLO1.5MGTABLET / ORAL2014-06-19ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A201446-001FALLBACK SOLO1.5MGTABLET / ORAL2014-06-196a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A201446-001FALLBACK SOLO1.5MGTABLET / ORAL2014-06-191c564ffb4f44…
2023-12-20 04:57 UTC2023-12A201446-001FALLBACK SOLO1.5MGTABLET / ORAL2014-06-19ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A201446-001FALLBACK SOLO1.5MGTABLET / ORAL2014-06-19a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A201446-001FALLBACK SOLO1.5MGTABLET / ORAL2014-06-199b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A201446-001FALLBACK SOLO1.5MGTABLET / ORAL2014-06-19a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A201446-001FALLBACK SOLO1.5MGTABLET / ORAL2014-06-193f0d92c62455…
2023-05-13 08:27 UTC2023-05A201446-001FALLBACK SOLO1.5MGTABLET / ORAL2014-06-19053a50430f4f…
2023-01-26 05:58 UTC2023-01A201446-001FALLBACK SOLO1.5MGTABLET / ORAL2014-06-193bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A201446-001FALLBACK SOLO1.5MGTABLET / ORAL2014-06-193a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A201446-001FALLBACK SOLO1.5MGTABLET / ORAL2014-06-19f41ea6bd6efb…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
92dcd064-5da0-29b6-e053-2a95a90a1bf192dcd064-5d9f-29b6-e053-2a95a90a1bf12019-09-18WarningsExact identifier
spl id: 92dcd064-5da0-29b6-e053-2a95a90a1bf1
spl set id: 92dcd064-5d9f-29b6-e053-2a95a90a1bf1

Reported adverse events (FAERS/openFDA)#

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