Birth Ease

Manufacturer: King Bio Inc.
Effective date: 2014-04-17
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-06-01 02:05:36

Label at a glance#

ProductBirth Ease

Active ingredientALETRIS FARINOSA ROOT, APIS MELLIFERA, ARNICA MONTANA, ATROPA BELLADONNA, CAULOPHYLLUM THALICTROIDES ROOT, MATRICARIA RECUTITA, BLACK COHOSH, IRON, POTASSIUM CARBONATE, JUNIPERUS SABINA LEAFY TWIG, CLAVICEPS PURPUREA SCLEROTIUM, VIBURNUM OPULUS BARK

Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Drug Facts__________________________________________________________________________________________________________

HPUS active ingredients: Aletrus farinosa, Apis mellifica, Arnica montana, Belladonna, Caulophyllum thalictroides, Chamomilla, Cimicifuga racemosa, Ferrum metallicum, Kali carbonicum, Sabina, Secale cornutum, Viburnum opulus. Equal volumes of each ingredient in 10X, 30X, 100X, 1M, LM1, LM2, LM3 potencies.

INDICATIONS & USAGE SECTION

Uses for temporary relief of: Muscular pains, stinging pain, tenderness over abdomen, vaginal dryness and heat, tender nipples, spasmodic labor pains, restlessness, extreme backache.

INACTIVE INGREDIENT SECTION

Inactive Ingredients:

Bio-Energetically Enhanced™ pure water, citric acid and potassium sorbate.

WARNINGS SECTION

Warnings

Stop use and ask your doctor if symptoms persist or worsen.
If pregnant or breast-feeding, take only on advice of a healthcare professional.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

Directions

Initially, depress pump until primed.
Spray one dose directly into mouth.
Adults: 12 and up: 3 sprays 3 times per day.
Use additionally as needed, up to 6 times per day.

OTHER SAFETY INFORMATION

Tamper resistant for your protection. Use only if safety seal is intact.

OTC - PURPOSE SECTION

Uses for temporary relief of:

muscular pains
stinging pain
tenderness over abdomen
vaginal dryness and heat
tender nipples
spasmodic labor pains
restlessness
extreme backache

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
910c1bd7-67d1-44c7-ad4f-9445f827edcc	Product name	1	20230808

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
57955-0002-2	2020-01-31	C162847	48780-1	9d75b9d1-2b02-f424-e053-dadaa90a57ce	Birth Ease™

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
57955-0002-2	Birth Ease	59 mL in 1 BOTTLE, SPRAY	LIQUID	59		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57955-0002	BIRTH EASE (ALETRIS FARINOSA, APIS MELLIFICA, ARNICA MONTANA, BELLADONNA, CAULOPHYLLUM THALICTROIDES, CHAMOMILLA, CIMICIFUGA RACEMOSA, FERRUM METALLICUM, KALI CARBONICUM, SABINA, SECALE CORNUTUM, VIBURNUM OPULUS) LIQUID [KING BIO INC.]	1	Legacy NDC, 1 package rows	20140417_10fd5bfe-2a66-4c82-8640-cf9bc837ab82.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
ALETRIS FARINOSA ROOT	ACTIVE INGREDIENT	O021JGR97X	1
APIS MELLIFERA	ACTIVE INGREDIENT	7S82P3R43Z	1
ARNICA MONTANA	ACTIVE INGREDIENT	O80TY208ZW	1
ATROPA BELLADONNA	ACTIVE INGREDIENT	WQZ3G9PF0H	1
BLACK COHOSH	ACTIVE INGREDIENT	K73E24S6X9	1
CAULOPHYLLUM THALICTROIDES ROOT	ACTIVE INGREDIENT	JTJ6HH6YEH	1
CLAVICEPS PURPUREA SCLEROTIUM	ACTIVE INGREDIENT	01G9XEA93N	1
IRON	ACTIVE INGREDIENT	E1UOL152H7	1
JUNIPERUS SABINA LEAFY TWIG	ACTIVE INGREDIENT	Z5BEX9K2G1	1
MATRICARIA RECUTITA	ACTIVE INGREDIENT	G0R4UBI2ZZ	1
POTASSIUM CARBONATE	ACTIVE INGREDIENT	BQN1B9B9HA	1
VIBURNUM OPULUS BARK	ACTIVE INGREDIENT	T1UG6H6805	1
ALETRIS FARINOSA ROOT	ACTIVE MOIETY	O021JGR97X	1
APIS MELLIFERA	ACTIVE MOIETY	7S82P3R43Z	1
ARNICA MONTANA	ACTIVE MOIETY	O80TY208ZW	1
ATROPA BELLADONNA	ACTIVE MOIETY	WQZ3G9PF0H	1
BLACK COHOSH	ACTIVE MOIETY	K73E24S6X9	1
CARBONATE ION	ACTIVE MOIETY	7UJQ5OPE7D	1
CAULOPHYLLUM THALICTROIDES ROOT	ACTIVE MOIETY	JTJ6HH6YEH	1
CLAVICEPS PURPUREA SCLEROTIUM	ACTIVE MOIETY	01G9XEA93N	1
IRON	ACTIVE MOIETY	E1UOL152H7	1
JUNIPERUS SABINA LEAFY TWIG	ACTIVE MOIETY	Z5BEX9K2G1	1
MATRICARIA RECUTITA	ACTIVE MOIETY	G0R4UBI2ZZ	1
VIBURNUM OPULUS BARK	ACTIVE MOIETY	T1UG6H6805	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	1
POTASSIUM SORBATE	INACTIVE INGREDIENT	1VPU26JZZ4	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

Birth Ease
Aletris farinosa, Apis mellifica, Arnica montana, Belladonna, Caulophyllum thalictroides, Chamomilla, Cimicifuga racemosa, Ferrum metallicum, Kali carbonicum, Sabina, Secale cornutum, Viburnum opulus
ALETRIS FARINOSA ROOT
APIS MELLIFERA
ARNICA MONTANA
ATROPA BELLADONNA
CAULOPHYLLUM THALICTROIDES ROOT
MATRICARIA RECUTITA
BLACK COHOSH
IRON
POTASSIUM CARBONATE
CARBONATE ION
JUNIPERUS SABINA LEAFY TWIG
CLAVICEPS PURPUREA SCLEROTIUM
VIBURNUM OPULUS BARK
WATER
CITRIC ACID MONOHYDRATE
POTASSIUM SORBATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
57955-0002	57955-0002-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ALETRIS FARINOSA ROOT	O021JGR97X	ACTIB
APIS MELLIFERA	7S82P3R43Z	ACTIB
ARNICA MONTANA	O80TY208ZW	ACTIB
ATROPA BELLADONNA	WQZ3G9PF0H	ACTIB
CAULOPHYLLUM THALICTROIDES ROOT	JTJ6HH6YEH	ACTIB
MATRICARIA RECUTITA	G0R4UBI2ZZ	ACTIB
BLACK COHOSH	K73E24S6X9	ACTIB
IRON	E1UOL152H7	ACTIB
POTASSIUM CARBONATE	BQN1B9B9HA	ACTIB
JUNIPERUS SABINA LEAFY TWIG	Z5BEX9K2G1	ACTIB
CLAVICEPS PURPUREA SCLEROTIUM	01G9XEA93N	ACTIB
VIBURNUM OPULUS BARK	T1UG6H6805	ACTIB
WATER	059QF0KO0R	IACT
CITRIC ACID MONOHYDRATE	2968PHW8QP	IACT
POTASSIUM SORBATE	1VPU26JZZ4	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 107 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, SOLUTION / INTRAVENOUS		396 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / INTRABURSAL	ADJ PH		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / NASAL	2.8 mg/1ml		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / INTRAMUSCULAR		28 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SWAB / TOPICAL	0.05 %w/w		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	CAPSULE / ORAL		238 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / SUBCUTANEOUS		28 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET / ORAL	914 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION/ DROPS / TOPICAL	0.01 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	LIQUID / RESPIRATORY (INHALATION)	0.13 %w/w		Exact identifier — unii candidate 88 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	SYRUP / ORAL	2 mg/1ml		Exact identifier — unii candidate 19 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	LIQUID / ORAL		114 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	TABLET, EXTENDED RELEASE / ORAL	0.2 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	SOLUTION / RECTAL	6.67 %w/v		Exact identifier — unii candidate 19 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET, CHEWABLE / ORAL	7 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, SOLUTION / INTRA-ARTICULAR	ADJ PH		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / INTRASYNOVIAL	ADJ PH		Exact identifier — unii candidate 88 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	0.2 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	SOLUTION / ORAL	1000 mg/15ml		Exact identifier — unii candidate 19 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SPRAY / NASAL		9 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / PERIDURAL	NA		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	POWDER, FOR SOLUTION / TOPICAL	NA		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SUSPENSION / RESPIRATORY (INHALATION)	0.03 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SUSPENSION, EXTENDED RELEASE / ORAL	140.8 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	GEL / TOPICAL		1 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	AEROSOL, FOAM / RECTAL		7 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / INTRACARDIAC	1.05 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / EPIDURAL	0.02 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	CREAM / VAGINAL	0.49 %w/w		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION/ DROPS / AURICULAR (OTIC)	0.04 %w/w		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, SOLUTION, CONCENTRATE / INTRAOCULAR		1 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET, EFFERVESCENT / ORAL	460 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		38 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	CONCENTRATE / ORAL		1 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SUSPENSION/ DROPS / ORAL		19 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET, ORALLY DISINTEGRATING / ORAL		83 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / INTRAVENOUS	2068 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	SPRAY, METERED / NASAL	0.06 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET, FILM COATED / ORAL		42 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / INTRATHECAL	ADJ PH		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	CREAM / TOPICAL		4 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	TROCHE / ORAL	12 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	CAPSULE, EXTENDED RELEASE / ORAL		101 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SHAMPOO, SUSPENSION / TOPICAL	0.25 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET, COATED / ORAL	NA		Exact identifier — unii candidate 88 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	TABLET, COATED / ORAL	NA		Exact identifier — unii candidate 19 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	POWDER, FOR SUSPENSION / ORAL		840 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, SOLUTION / INTRAMUSCULAR		26 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / INTRAVENOUS		10 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	SUSPENSION / ORAL		400 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	DOUCHE / VAGINAL	0.07 %w/w		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / ORAL		446 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	LOTION / TOPICAL	0.85 %w/w		Exact identifier — unii candidate 88 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	CAPSULE / ORAL	NA		Exact identifier — unii candidate 19 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	DROPS / ORAL	NA		Exact identifier — unii candidate 88 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	POWDER, FOR SUSPENSION / ORAL		19 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / INTRAPLEURAL	ADJ PH		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	ELIXIR / ORAL	100 mg/5ml		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET, EXTENDED RELEASE / ORAL		45 mg	Exact identifier — unii candidate 88 equally ranked IID candidates

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
e21e4c7e-70b8-4660-8a29-aae15fefbb18			10fd5bfe-2a66-4c82-8640-cf9bc837ab82	2014-04-17	Warnings	Exact identifier spl id: e21e4c7e-70b8-4660-8a29-aae15fefbb18 spl set id: 10fd5bfe-2a66-4c82-8640-cf9bc837ab82

Reported adverse events (FAERS/openFDA)#

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