Insomulex

Manufacturer: Hello Life, Inc. | King Bio Inc.
Effective date: 2018-12-26
Label type: HUMAN OTC DRUG LABEL
Version: 6
Source: full-release
Hydrated at: 2026-06-01 02:10:39

Label at a glance#

ProductInsomulex Insomnia Symptom Relief

Active ingredientAESCULUS HIPPOCASTANUM FLOWER, AMBERGRIS, AVENA SATIVA FLOWERING TOP, BARIUM CARBONATE, CAMPHOR (NATURAL), CINCHONA OFFICINALIS BARK, ANAMIRTA COCCULUS SEED, ARABICA COFFEE BEAN, CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT, GELSEMIUM SEMPERVIRENS ROOT, HYOSCYAMUS NIGER, STRYCHNOS IGNATII SEED, POTASSIUM BROMIDE, POTASSIUM PHOSPHATE, DIBASIC, MAGNESIUM CARBONATE, HYDROCHLORIC ACID, SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE, PASSIFLORA INCARNATA FLOWERING TOP, ARSENIC TRIOXIDE, SCUTELLARIA LATERIFLORA, SULFUR, VALERIAN, ZINC

Label structure10 sections

Indications and uses

For the temporary relief of symptoms commonly associated with insomnia, including: worry restless tossing light sleeping overactive mind

Dosage and administration

add recommended dosage into 8-12 oz. of purified (non-chlorinated) water and drink, or dispense Insomulex directly into mouth. for optimal benefit, use Insomulex prior to bedtime, naptime, or returning to either after a disruption. Dosage by Weight: 30-50 lbs (13.6-22.6 kg) 1/2 mL 50+ lbs (22.6+ kg) 1 mL

Storage and handling

do not use if tamper seal is broken store in a cool, dry place product must not come in contact with metal do not store next to electrical devices or appliances

Contacts and useful links#

PhoneLabel contact1.800.875.0850

Websitewww.insomulex.com

www.insomulex.com

Label contents#

Full prescribing information#

Active Ingredients (per dose)

OTC - ACTIVE INGREDIENT SECTION

Aesculus hipp, flos, Baryta carb, Cypripedium, Hyoscyamus, Mag carb, Sulphur HPUS

Ambra, Ignatia HPUS

Arsenicum alb HPUS

Avena, Cocculus, Coffea cruda, Gelsemium, Kali phos HPUS

Camphora, Kali brom, Passiflora, Scutellaria HPUS

Cinchona HPUS

Muriaticum ac, Valeriana, Zinc met HPUS

Nat phos HPUS

Each ingredient contains equal volumes of 10X, 30X, and LM1 potencies. The letters "HPUS" indicate that the components in thsi prodct are officially monographed in the Homeopathic Pharmacopeia of the United States.

Product indications are based on Homeopathic Materia Medica.

Purpose

OTC - PURPOSE SECTION

Aesculus hipp, flos, Baryta carb, Cypripedium, Hyoscyamus, Mag carb, Sulphur HPUS.....................................Trouble sleeping

Ambra, Ignatia HPUS...................................................................................................................................................Worry

Arsenicum alb HPUS....................................................................................................................................................Fear

Avena, Cocculus, Coffea cruda, Gelsemium, Kali phos HPUS....................................................................Nervous Exhaustion

Camphora, Kali brom, Passiflora, Scutellaria HPUS.............................................................................................Restlessness

Cinchona HPUS................................................................................................................................................Anxiousness

Muriaticum ac, Valeriana, Zinc met HPUS.................................................................................................Tossing and Turning

Nat phos HPUS..............................................................................................................Tiredness during day, staying up late

Each ingredient contains equal volumes of 10X, 30X, and LM1 potencies. The letters “HPUS” indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States. Indications are based on Homeopathic Materia Medica.

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of symptoms commonly associated with insomnia, including:

worry
restless tossing
light sleeping
overactive mind

Warnings

WARNINGS SECTION

Ask a doctor before use if

you are taking any other medications
you have a medical condition

OTC - WHEN USING SECTION

When using this product, use only as directed.

OTC - STOP USE SECTION

Stop use and ask a doctor if symptoms persist or worsen.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, use only on the advice of a physician.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

add recommended dosage into 8-12 oz. of purified (non-chlorinated) water and drink, or dispense Insomulex directly into mouth.
for optimal benefit, use Insomulex prior to bedtime, naptime, or returning to either after a disruption.

Dosage by Weight:

30-50 lbs (13.6-22.6 kg) 1/2 mL

50+ lbs (22.6+ kg) 1 mL

Other Information

STORAGE AND HANDLING SECTION

do not use if tamper seal is broken
store in a cool, dry place
product must not come in contact with metal
do not store next to electrical devices or appliances

Inactive Ingredients

INACTIVE INGREDIENT SECTION

citric acid, potassium sorbate, purified ionized mineral water

Questions or comments?

OTC - QUESTIONS SECTION

You can email us at info@hellolife.net or give us a call toll-free at 1.800.875.0850. Monday through Friday 9am-5pm.

DESCRIPTION SECTION

30-day supply
dropper included
Insomulex is made without alcohol or sugar. No gluten added.

Mftd for: HelloLife, LLC.
4460 44th St. SE, Ste. C-600
Grand Rapids, MI 49512
FDA Pharmaceutical Establishment
#1053442, #3009727070
www.insomulex.com

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 49726-026-02

INSOMULEX ^TM

Insomnia Symptom Relief

For temporary relief of symptoms commonly associated with insomnia, including:

worry
restless tossing
light sleeping
overactive mind

2 FL OZ (59 mL)

Homeopathic (OTC) Medicine

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
efd58dcf-540a-4531-8766-e713129ca6f2	Product name	1	20250307
4b7700e3-6e0e-45e5-9d22-6f754d61386e	Product name	2	20250304
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
63f39a63-5cd1-4016-bd86-2bbb0f6c3139	Product name	3	20240506
e5a77e9c-c528-733a-173d-914a234c024b	Product name	5	20240506
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
49726-026-02	2020-01-31	C162847	48780-1	9d75b9d0-a16e-f424-e053-dadaa90a57ce	e4d43536-7ea2-4049-9ed8-446d5feb7331

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
49726-026-02	InsomulexInsomnia Symptom Relief	59 mL in 1 BOTTLE, DROPPER	LIQUID	59		6
49726-026-02	InsomulexInsomnia Symptom Relief	1 in 1 CARTON	LIQUID	1		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49726-026	INSOMULEX INSOMNIA SYMPTOM RELIEF (AESCULUS HIPP, FLOS, AMBRA, ARSENICUM ALB, AVENA, BARYTA CARB, CAMPHORA, CINCHONA, COCCULUS, COFFEA CRUDA, CYPRIPEDIUM, GELSEMIUM, HYOSCYAMUS, IGNATIA, KALI BROM, KALI PHOS, MAG CARB, MURIATICUM AC, NAT PHOS, PASSIFLORA, SCUTELLARIA, SULPHUR, VALERIANA, ZINC MET) LIQUID [HELLO LIFE, INC.]	6	Legacy NDC, 2 package rows	20181227_e4d43536-7ea2-4049-9ed8-446d5feb7331.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
AESCULUS HIPPOCASTANUM FLOWER	ACTIVE INGREDIENT	KK0Z92II8M	4
AMBERGRIS	ACTIVE INGREDIENT	XTC0D02P6C	4
ANAMIRTA COCCULUS SEED	ACTIVE INGREDIENT	810258W28U	4
ARABICA COFFEE BEAN	ACTIVE INGREDIENT	3SW678MX72	4
ARSENIC TRIOXIDE	ACTIVE INGREDIENT	S7V92P67HO	4
AVENA SATIVA FLOWERING TOP	ACTIVE INGREDIENT	MA9CQJ3F7F	4
BARIUM CARBONATE	ACTIVE INGREDIENT	6P669D8HQ8	4
CAMPHOR (NATURAL)	ACTIVE INGREDIENT	N20HL7Q941	4
CINCHONA OFFICINALIS BARK	ACTIVE INGREDIENT	S003A158SB	4
CYPRIPEDIUM PARVIFOLUM ROOT	ACTIVE INGREDIENT	21Y9GZ1LZA	4
GELSEMIUM SEMPERVIRENS ROOT	ACTIVE INGREDIENT	639KR60Q1Q	4
HYDROCHLORIC ACID	ACTIVE INGREDIENT	QTT17582CB	4
HYOSCYAMUS NIGER	ACTIVE INGREDIENT	4WRK2153H3	4
MAGNESIUM CARBONATE	ACTIVE INGREDIENT	0E53J927NA	4
PASSIFLORA INCARNATA FLOWERING TOP	ACTIVE INGREDIENT	CLF5YFS11O	4
POTASSIUM BROMIDE	ACTIVE INGREDIENT	OSD78555ZM	4
POTASSIUM PHOSPHATE, DIBASIC	ACTIVE INGREDIENT	CI71S98N1Z	4
SCUTELLARIA LATERIFLORA	ACTIVE INGREDIENT	7BP4DH5PDC	4
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE	ACTIVE INGREDIENT	70WT22SF4B	4
STRYCHNOS IGNATII SEED	ACTIVE INGREDIENT	1NM3M2487K	4
SULFUR	ACTIVE INGREDIENT	70FD1KFU70	4
VALERIAN	ACTIVE INGREDIENT	JWF5YAW3QW	4
ZINC	ACTIVE INGREDIENT	J41CSQ7QDS	4
AESCULUS HIPPOCASTANUM FLOWER	ACTIVE MOIETY	KK0Z92II8M	4
AMBERGRIS	ACTIVE MOIETY	XTC0D02P6C	4
ANAMIRTA COCCULUS SEED	ACTIVE MOIETY	810258W28U	4
ARABICA COFFEE BEAN	ACTIVE MOIETY	3SW678MX72	4
ARSENIC CATION (3+)	ACTIVE MOIETY	C96613F5AV	4
AVENA SATIVA FLOWERING TOP	ACTIVE MOIETY	MA9CQJ3F7F	4
BARIUM CATION	ACTIVE MOIETY	V645272HLN	4
BROMIDE ION	ACTIVE MOIETY	952902IX06	4
CAMPHOR (NATURAL)	ACTIVE MOIETY	N20HL7Q941	4
CARBONATE ION	ACTIVE MOIETY	7UJQ5OPE7D	4
CINCHONA OFFICINALIS BARK	ACTIVE MOIETY	S003A158SB	4
CYPRIPEDIUM PARVIFOLUM ROOT	ACTIVE MOIETY	21Y9GZ1LZA	4
GELSEMIUM SEMPERVIRENS ROOT	ACTIVE MOIETY	639KR60Q1Q	4
HYDROCHLORIC ACID	ACTIVE MOIETY	QTT17582CB	4
HYOSCYAMUS NIGER	ACTIVE MOIETY	4WRK2153H3	4
PASSIFLORA INCARNATA FLOWERING TOP	ACTIVE MOIETY	CLF5YFS11O	4
PHOSPHATE ION	ACTIVE MOIETY	NK08V8K8HR	4
SCUTELLARIA LATERIFLORA	ACTIVE MOIETY	7BP4DH5PDC	4
STRYCHNOS IGNATII SEED	ACTIVE MOIETY	1NM3M2487K	4
SULFUR	ACTIVE MOIETY	70FD1KFU70	4
VALERIAN	ACTIVE MOIETY	JWF5YAW3QW	4
ZINC	ACTIVE MOIETY	J41CSQ7QDS	4
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	4
POTASSIUM SORBATE	INACTIVE INGREDIENT	1VPU26JZZ4	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	4

Products#

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

DailyMed product names page 1 of 1 · 33 matching rows.

Insomulex Insomnia Symptom Relief
Aesculus hipp, flos, Ambra, Arsenicum alb, Avena, Baryta carb, Camphora, Cinchona, Cocculus, Coffea cruda, Cypripedium, Gelsemium, Hyoscyamus, Ignatia, Kali brom, Kali phos, Mag carb, Muriaticum ac, Nat phos, Passiflora, Scutellaria, Sulphur, Valeriana, Zinc met
CITRIC ACID MONOHYDRATE
POTASSIUM SORBATE
WATER
AESCULUS HIPPOCASTANUM FLOWER
AMBERGRIS
AVENA SATIVA FLOWERING TOP
BARIUM CARBONATE
BARIUM CATION
CAMPHOR (NATURAL)
CINCHONA OFFICINALIS BARK
ANAMIRTA COCCULUS SEED
ARABICA COFFEE BEAN
CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT
GELSEMIUM SEMPERVIRENS ROOT
HYOSCYAMUS NIGER
STRYCHNOS IGNATII SEED
POTASSIUM BROMIDE
BROMIDE ION
POTASSIUM PHOSPHATE, DIBASIC
PHOSPHATE ION
MAGNESIUM CARBONATE
CARBONATE ION
HYDROCHLORIC ACID
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE
PASSIFLORA INCARNATA FLOWERING TOP
ARSENIC TRIOXIDE
ARSENIC CATION (3+)
SCUTELLARIA LATERIFLORA
SULFUR
VALERIAN
ZINC

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
49726-026	49726-026-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CITRIC ACID MONOHYDRATE	2968PHW8QP	IACT
POTASSIUM SORBATE	1VPU26JZZ4	IACT
WATER	059QF0KO0R	IACT
AESCULUS HIPPOCASTANUM FLOWER	KK0Z92II8M	ACTIB
AMBERGRIS	XTC0D02P6C	ACTIB
AVENA SATIVA FLOWERING TOP	MA9CQJ3F7F	ACTIB
BARIUM CARBONATE	6P669D8HQ8	ACTIB
CAMPHOR (NATURAL)	N20HL7Q941	ACTIB
CINCHONA OFFICINALIS BARK	S003A158SB	ACTIB
ANAMIRTA COCCULUS SEED	810258W28U	ACTIB
ARABICA COFFEE BEAN	3SW678MX72	ACTIB
CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT	21Y9GZ1LZA	ACTIB
GELSEMIUM SEMPERVIRENS ROOT	639KR60Q1Q	ACTIB
HYOSCYAMUS NIGER	4WRK2153H3	ACTIB
STRYCHNOS IGNATII SEED	1NM3M2487K	ACTIB
POTASSIUM BROMIDE	OSD78555ZM	ACTIB
POTASSIUM PHOSPHATE, DIBASIC	CI71S98N1Z	ACTIB
MAGNESIUM CARBONATE	0E53J927NA	ACTIB
HYDROCHLORIC ACID	QTT17582CB	ACTIB
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE	70WT22SF4B	ACTIB
PASSIFLORA INCARNATA FLOWERING TOP	CLF5YFS11O	ACTIB
ARSENIC TRIOXIDE	S7V92P67HO	ACTIB
SCUTELLARIA LATERIFLORA	7BP4DH5PDC	ACTIB
SULFUR	70FD1KFU70	ACTIB
VALERIAN	JWF5YAW3QW	ACTIB
ZINC	J41CSQ7QDS	ACTIB

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, CONCENTRATE / IRRIGATION		1 mg	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	LOTION / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 19 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
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	FILM / SUBLINGUAL		10 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	NA		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 / INTRATHECAL	ADJ PH		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SYSTEM / TOPICAL	0.2 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / TOPICAL		17 mg	Exact identifier — unii candidate 88 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	TABLET / ORAL	914 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	INJECTION, SOLUTION, CONCENTRATE / INTRAOCULAR		1 mg	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
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	GEL / TOPICAL		1 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOAP / TOPICAL	0.5 %w/w		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, SOLUTION / SUBCUTANEOUS		26 mg	Exact identifier — unii candidate 88 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	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		385 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	OINTMENT / TOPICAL		1 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
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	CREAM / TOPICAL	0.25 %w/w		Exact identifier — unii candidate 19 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET / SUBLINGUAL		24 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INHALANT / RESPIRATORY (INHALATION)	NA		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
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	SPRAY / NASAL		9 mg	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	INJECTION / SOFT TISSUE	ADJ PH		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / INTRAPLEURAL	ADJ PH		Exact identifier — unii candidate 88 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	SOLUTION / RECTAL	6.67 %w/v		Exact identifier — unii candidate 19 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	CONCENTRATE / ORAL		1 mg	Exact identifier — unii candidate 19 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	INJECTION / EPIDURAL	0.02 %w/v		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	POWDER, FOR SUSPENSION / ORAL		840 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
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	SPRAY, METERED / NASAL		2 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	POWDER / ORAL		840 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
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / BUCCAL	NA		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
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	DROPS / ORAL	NA		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	GRANULE, FOR SUSPENSION / ORAL		113 mg	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	CAPSULE, EXTENDED RELEASE / ORAL		101 mg	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
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / INTRA-ARTICULAR	ADJ PH		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	INJECTION / INTRALESIONAL	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
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	SUSPENSION, EXTENDED RELEASE / ORAL	140.8 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / INFILTRATION	0.02 %w/v		Exact identifier — unii candidate 88 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	SOLUTION / INTRAMUSCULAR	0.05 %w/v		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
7df1b93e-7481-aada-e053-2991aa0a6e99			e4d43536-7ea2-4049-9ed8-446d5feb7331	2018-12-26	Warnings	Exact identifier spl id: 7df1b93e-7481-aada-e053-2991aa0a6e99 spl set id: e4d43536-7ea2-4049-9ed8-446d5feb7331

Reported adverse events (FAERS/openFDA)#

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