FDA.reportPublic FDA data

PostDay One-Step

Manufacturer
Home Health Brands, LLC
Effective date
2025-04-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:59:53

Label at a glance#

ProductPostDay One-Step
Active ingredientLEVONORGESTREL
Label structure10 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 after 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 • 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 the blister seal is broken or missing • store at 20-25°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)

Warnings

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

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 after 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
• 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 the blister seal is broken or missing
• store at 20-25°C (68° to 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, potato starch, talc

Questions?

OTC - QUESTIONS SECTION

Call 833-337-6872

SPL UNCLASSIFIED SECTION

*Compare to the active ingredient of Plan B One-Step®

One Tablet. One Step.

Not for regular birth control.

• 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

DISTRIBUTED BY
HomeHealthBrands, LLC
301 W. Atlantic Ave. ste. 05
Delray Beach, FL 33444
833-337-6872
sales@homehealthbrands.com

MANUFACTURED BY
Glenmark Pharmaceuticals Limited
Covale-Bardez
Goa 403515, INDIA

MADE IN INDIA

*This product is not manufactured or distributed by Foundation Consumer Healthcare LLC, distributor of Plan B One-Step®.

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PostDay One-StepPostDay One-Step

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
483325levonorgestrel 1.5 MG Oral TabletPSN1
2049247PostDay One-Step Emergency Contraceptive 1.5 MG Oral TabletPSN1
2049247levonorgestrel 1.5 MG Oral Tablet [PostDay One-Step]SBD1
483325levonorgestrel 1.5 MG Oral TabletSCD1
2049247PostDay One-Step 1.5 MG Oral TabletSY1
2049247PostDay One-Step Emergency Contraceptive 1.5 MG Oral TabletSY1

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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
85506-100-10PostDay One-Step1 in 1 CARTONTABLET11
85506-100-10PostDay One-Step1 in 1 BLISTER PACKTABLET11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85506-100POSTDAY ONE-STEP (LEVONORGESTREL) TABLET [HOME HEALTH BRANDS, LLC]1Current NDC, 2 package rows20250430_01c8c95c-6fbe-4068-915d-74418a6bb570.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72657-108-12EA - Each72657-108a7b4f7a5-3f39-441d-960b-4a06143d23e312025-12-16

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85506-10085506-100-10
72657-108

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
LEVONORGESTREL5W7SIA7YZWACTIB
SILICON DIOXIDEETJ7Z6XBU4IACT
STARCH, CORNO8232NY3SJIACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
MAGNESIUM STEARATE70097M6I30IACT
STARCH, POTATO8I089SAH3TIACT
TALC7SEV7J4R1UIACT

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 44.

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
A207044-001LEVONORGESTRELLEVONORGESTREL1.5MGTABLET / ORAL2016-03-25

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 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-25c2088c7a36db…
2026-09-14 22:38:342026-08A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-2584e616aacf4f…
2026-08-18 06:07:402026-07A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-258072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-255c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-255d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-254b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-2574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-25bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-25782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-2587673890dc5c…
2021-03-12 10:30 UTC2021-03A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-255aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-258869cabd3fbd…
2020-11-12 02:37 UTC2020-11A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-25c0c555d07b60…
2019-12-14 00:12 UTC2019-12A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-253f01610625f2…
2019-09-15 20:21 UTC2019-09A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-25b00525d2431f…
2019-07-19 19:46 UTC2019-07A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-25ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-256a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-251c564ffb4f44…
2023-12-20 04:57 UTC2023-12A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-25ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-25a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-259b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-25a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-253f0d92c62455…
2023-05-13 08:27 UTC2023-05A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-25053a50430f4f…
2023-01-26 05:58 UTC2023-01A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-253bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A207044-001LEVONORGESTREL1.5MGTABLET / ORAL2016-03-253a93d1ddd44b…

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
SheWiseLEVONORGESTRELGLENMARK THERAPEUTICS INC., USA7be13a7e-b4ff-4fe1-82a6-f9914596d72a2026-07-15WarningsExact identifier
ndc (product): 72657-108
PostDay One-StepLEVONORGESTRELHome Health Brands, LLC01c8c95c-6fbe-4068-915d-74418a6bb5702025-04-23WarningsExact identifier
ndc (package): 85506-100-10
ndc (product): 85506-100
ndc11 (package): 85506010010
spl id: 5e63d013-fee0-4ed8-bb10-96053a391952
spl set id: 01c8c95c-6fbe-4068-915d-74418a6bb570

Reported adverse events (FAERS/openFDA)#

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