FDA.reportPublic FDA data

Morning After Pill

Manufacturer
Cadence Health Inc | Naari Pte. Limited | Haupt Pharma Muenster GmbH
Effective date
2025-02-14
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:55:27

Label at a glance#

ProductMorning After Pill
Active ingredientLEVONORGESTREL
Label structure16 sections

Dosage and administration

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 of taking the medication, call a healthcare professional to find out if you should repeat the dose

Storage and handling

read the instructions, warnings, and enclosed product leaflet before use do not use if carton is open or blister seal is broken or missing store at 20° to 25°C (68° to 77°F)

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Levonorgestrel 1.5 mg

Purpose

OTC - PURPOSE SECTION

Emergency contraceptive

Use

INDICATIONS & USAGE SECTION

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

Allergy alert

SPL UNCLASSIFIED SECTION

Do not use if you have ever had an allergic reaction to levonorgestrel

Sexually transmitted diseases (STDs) alert

SPL UNCLASSIFIED SECTION

This product does not protect against HIV/AIDS or other STDs

Do not use

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

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.

OTC - WHEN USING SECTION

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 reach of children. In case of overdose, get medical help or contact a Poison Control center right away 1-800-222-1222

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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 of taking the medication, call a healthcare professional to find out if you should repeat the dose

Other information

STORAGE AND HANDLING SECTION

  • read the instructions, warnings, and enclosed product leaflet before use
  • do not use if carton is open or blister seal is broken or missing
  • store at 20° to 25°C (68° to 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, FD&C Yellow No.6 aluminum lake, lactose monohydrate, magnesium stearate, and pregelatinized starch

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-877-862-7455
Monday - Friday 8 AM - 5 PM CST or visit us at cadenceotc.com

SPL UNCLASSIFIED SECTION

Manufactured for:
Cadence OTC

Oakland CA, 94612

NDC 73436-2859-1


Product made in Germany
Issued: September 2023

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1. NDC 73436-2859-1

Morning After Pill TM

Levonorgestrel 1.5 mg

Emergency contraceptive

Reduces chance of pregnancy after unprotected sex

Not for regular birth control

Won't interefere with your ability to get pregnant later

  • The sooner you take it, the more effective it will be
  • Take as soon as possible within 72 hours (3 days) after unprotected sex
  • Will not harm an existing pregnancy

1 TABLET LEVONORGESTREL 1.5MG

image descriptionimage description

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Morning After PillMorning After Pill

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
483325levonorgestrel 1.5 MG Oral TabletPSN4
1657617Morning After 1.5 MG Oral TabletPSN4
1657617levonorgestrel 1.5 MG Oral Tablet [Morning After]SBD4
483325levonorgestrel 1.5 MG Oral TabletSCD4
1657617Morning After 1.5 MG Oral TabletSY4

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73436-2859-1Morning After Pill1 in 1 BLISTER PACKTABLET14
73436-2859-1Morning After Pill1 in 1 CARTONTABLET14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73436-2859MORNING AFTER PILL (LEVONORGESTREL) TABLET [CADENCE HEALTH INC]4Current NDC, 2 package rows20250217_fc5d29bb-4a4b-e61e-e053-6394a90a8a62.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73436-285973436-2859-1

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
FD&C YELLOW NO. 6H77VEI93A8IACT
STARCH, CORNO8232NY3SJIACT
MAGNESIUM STEARATE70097M6I30IACT
LEVONORGESTREL5W7SIA7YZWACTIB

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
A202380-001LEVONORGESTRELLEVONORGESTREL1.5MGTABLET / ORAL2015-05-29

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.

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 22:38:342026-08A202380-001LEVONORGESTREL1.5MGTABLET / ORAL2015-05-2984e616aacf4f…
2026-08-18 06:07:402026-07A202380-001LEVONORGESTREL1.5MGTABLET / ORAL2015-05-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202380-001LEVONORGESTREL1.5MGTABLET / ORAL2015-05-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202380-001LEVONORGESTREL1.5MGTABLET / ORAL2015-05-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A202380-001LEVONORGESTREL1.5MGTABLET / ORAL2015-05-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202380-001LEVONORGESTREL1.5MGTABLET / ORAL2015-05-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202380-001LEVONORGESTREL1.5MGTABLET / ORAL2015-05-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202380-001LEVONORGESTREL1.5MGTABLET / ORAL2015-05-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202380-001LEVONORGESTREL1.5MGTABLET / ORAL2015-05-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202380-001LEVONORGESTREL1.5MGTABLET / ORAL2015-05-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202380-001LEVONORGESTREL1.5MGTABLET / ORAL2015-05-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202380-001LEVONORGESTREL1.5MGTABLET / ORAL2015-05-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202380-001LEVONORGESTREL1.5MGTABLET / ORAL2015-05-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202380-001LEVONORGESTREL1.5MGTABLET / ORAL2015-05-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202380-001LEVONORGESTREL1.5MGTABLET / ORAL2015-05-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202380-001LEVONORGESTREL1.5MGTABLET / ORAL2015-05-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202380-001LEVONORGESTREL1.5MGTABLET / ORAL2015-05-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202380-001LEVONORGESTREL1.5MGTABLET / ORAL2015-05-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202380-001LEVONORGESTREL1.5MGTABLET / ORAL2015-05-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202380-001LEVONORGESTREL1.5MGTABLET / ORAL2015-05-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202380-001LEVONORGESTREL1.5MGTABLET / ORAL2015-05-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202380-001LEVONORGESTREL1.5MGTABLET / ORAL2015-05-29782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202380-001LEVONORGESTREL1.5MGTABLET / ORAL2015-05-2987673890dc5c…
2021-03-12 10:30 UTC2021-03A202380-001LEVONORGESTREL1.5MGTABLET / ORAL2015-05-295aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A202380-001LEVONORGESTREL1.5MGTABLET / ORAL2015-05-298869cabd3fbd…
2020-11-12 02:37 UTC2020-11A202380-001LEVONORGESTREL1.5MGTABLET / ORAL2015-05-29c0c555d07b60…
2019-12-14 00:12 UTC2019-12A202380-001LEVONORGESTREL1.5MGTABLET / ORAL2015-05-293f01610625f2…
2019-09-15 20:21 UTC2019-09A202380-001LEVONORGESTREL1.5MGTABLET / ORAL2015-05-29b00525d2431f…
2019-07-19 19:46 UTC2019-07A202380-001LEVONORGESTREL1.5MGTABLET / ORAL2015-05-29ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A202380-001LEVONORGESTREL1.5MGTABLET / ORAL2015-05-296a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A202380-001LEVONORGESTREL1.5MGTABLET / ORAL2015-05-291c564ffb4f44…
2023-12-20 04:57 UTC2023-12A202380-001LEVONORGESTREL1.5MGTABLET / ORAL2015-05-29ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A202380-001LEVONORGESTREL1.5MGTABLET / ORAL2015-05-29a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A202380-001LEVONORGESTREL1.5MGTABLET / ORAL2015-05-299b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A202380-001LEVONORGESTREL1.5MGTABLET / ORAL2015-05-29a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A202380-001LEVONORGESTREL1.5MGTABLET / ORAL2015-05-293f0d92c62455…
2023-05-13 08:27 UTC2023-05A202380-001LEVONORGESTREL1.5MGTABLET / ORAL2015-05-29053a50430f4f…
2023-01-26 05:58 UTC2023-01A202380-001LEVONORGESTREL1.5MGTABLET / ORAL2015-05-293bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A202380-001LEVONORGESTREL1.5MGTABLET / ORAL2015-05-293a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A202380-001LEVONORGESTREL1.5MGTABLET / ORAL2015-05-29f41ea6bd6efb…

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
Morning After PillLEVONORGESTRELCadence Health Incfc5d29bb-4a4b-e61e-e053-6394a90a8a622025-02-14WarningsExact identifier
ndc (package): 73436-2859-1
ndc (product): 73436-2859
ndc11 (package): 73436285901
spl id: 2e251776-063e-0e05-e063-6294a90a8e98
spl set id: fc5d29bb-4a4b-e61e-e053-6394a90a8a62

Reported adverse events (FAERS/openFDA)#

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