AT ONE WITH NATURE

Manufacturer: BIOCARE LABS INC. | RAANI CORPORATION
Effective date: 2012-12-27
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:34:07

Label at a glance#

ProductAT ONE WITH NATURE DRY AND ITCHY SCALP

Active ingredientPYRITHIONE ZINC

Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients:

Pyrithione Zinc 1%

OTC - PURPOSE SECTION

Purpose: Antidandruff, Anti-Seborrheic Dermatitis

INDICATIONS & USAGE SECTION

Use: Help prevent recurrence of flaking and itching associated with dandruff.

WARNINGS SECTION

Warnings:

For external use only.

OTC - WHEN USING SECTION

When using this product

Avoid getting into eyes. In event of contact, rinse eyes thoroughly with water.

OTC - ASK DOCTOR SECTION

Ask a doctor. before using this product if condition covers a large area of body.

OTC - STOP USE SECTION

Stop use and ask a doctor if. conditions worsens or does not improve after regular use as directed.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center immediately.

DOSAGE & ADMINISTRATION SECTION

Directions

Shake before using.
Wet hair thoroughly, and apply shampoo.Work up a rich lather, and massage the scalp with fingertips. Rinse and lather again.Allow second lather to stay on hair for 5 minutes.Rinse thoroughly and apply AtOne with Nature Itchy Scalp Conditioner and rinse, or Leave-In Conditioner.Proceed to style.
For best results, use at least twice a week or as directed by a doctor.

INACTIVE INGREDIENT SECTION

Inactive Ingredients

Water(Aqua), Ammonium Laureth Sulfate, Ammonium Lauryl Sulfate, Cocamide DEA, Polyquaternium-28, Cocamidopropyl Betaine,Menthol,Glycol Stearate, Magnesium Aluminum Silicate, Dihydrogenated Tallow Phthalic Acid, Propylene Glycol, Lamium Album Flower Extract, Pinus Sylvestris Cone Extract, Arctium Lappa(Burdock) Root Extract, Anthemis Nobilis(Chamomile) Flower Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Hedra Helix (Ivy) Leaf/Stem Extract, Arnica Montana Flower Extract, Nasturtium Officinale (Watercress) Flower/Leaf Extract, Allium Sativum (Garlic) Bulb Extract, Calendula Officinalis (Pot Marigold) Flower Extract, Tilia Cordata (Linden) Flower Extract, Centaurea Cyanus (Cornflower) Flower Extract, Chamomilla Recutita (Matricaria) Flower Extract, Hypericum Perfratum (St. John's Wort) Flower/Leaf/Stem Extract, Fragrance, DMDM Hydantion, Tetraodium EDTA, Citric Acid, Blue 1 (CI 42090) Argania spinosa (Argan) KERNEL Oil

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Biocare Shampoo 8 oz

Biocare Shampoo 16 oz

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
209884	zinc pyrithione 1 % Medicated Shampoo	PSN	1
209884	zinc pyrithione 10 MG/ML Medicated Shampoo	SCD	1
209884	zinc pyrithione 1 % Medicated Conditioner	SY	1
209884	zinc pyrithione 1 % Medicated Shampoo	SY	1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
54602-758-08	2019-11-27	C162847	48780-1	9855d018-ef12-cd31-e053-dbdaa90ab51a	48da6e99-10d3-41fe-9e56-9dd98568dd7d
54602-758-16	2019-11-27	C162847	48780-1	9855d018-ef12-cd31-e053-dbdaa90ab51a	48da6e99-10d3-41fe-9e56-9dd98568dd7d

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54602-758-08	AT ONE WITH NATUREDRY AND ITCHY SCALP	237 mL in 1 BOTTLE	SHAMPOO	237		1
54602-758-16	AT ONE WITH NATUREDRY AND ITCHY SCALP	473 mL in 1 BOTTLE	SHAMPOO	473		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54602-758	AT ONE WITH NATURE DRY AND ITCHY SCALP (PYRITHIONE ZINC) SHAMPOO [BIOCARE LABS INC.]	1	Legacy NDC, 2 package rows	20121229_48da6e99-10d3-41fe-9e56-9dd98568dd7d.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
PYRITHIONE ZINC	ACTIVE INGREDIENT	R953O2RHZ5	1
PYRITHIONE ZINC	ACTIVE MOIETY	R953O2RHZ5	1
AMMONIUM LAURETH-2 SULFATE	INACTIVE INGREDIENT	698O4Z48G6	1
AMMONIUM LAURYL SULFATE	INACTIVE INGREDIENT	Q7AO2R1M0B	1
ARCTIUM LAPPA ROOT	INACTIVE INGREDIENT	597E9BI3Z3	1
ARGAN OIL	INACTIVE INGREDIENT	4V59G5UW9X	1
ARNICA MONTANA FLOWER	INACTIVE INGREDIENT	OZ0E5Y15PZ	1
CALENDULA OFFICINALIS FLOWER	INACTIVE INGREDIENT	P0M7O4Y7YD	1
CENTAUREA CYANUS FLOWER	INACTIVE INGREDIENT	QZ239038YC	1
CHAMAEMELUM NOBILE FLOWER	INACTIVE INGREDIENT	O2T154T6OG	1
CHAMOMILE	INACTIVE INGREDIENT	FGL3685T2X	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	1
COCAMIDOPROPYL BETAINE	INACTIVE INGREDIENT	5OCF3O11KX	1
COCO DIETHANOLAMIDE	INACTIVE INGREDIENT	92005F972D	1
DIHYDROGENATED TALLOW PHTHALIC ACID AMIDE	INACTIVE INGREDIENT	1R81RPY10G	1
DMDM HYDANTOIN	INACTIVE INGREDIENT	BYR0546TOW	1
EDETATE SODIUM	INACTIVE INGREDIENT	MP1J8420LU	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	1
GARLIC	INACTIVE INGREDIENT	V1V998DC17	1
GLYCOL STEARATE	INACTIVE INGREDIENT	0324G66D0E	1
HEDERA HELIX LEAF	INACTIVE INGREDIENT	ZP9XFG71A7	1
HYPERICUM PERFORATUM	INACTIVE INGREDIENT	XK4IUX8MNB	1
LAMIUM ALBUM	INACTIVE INGREDIENT	046Y1357I6	1
MAGNESIUM ALUMINUM SILICATE	INACTIVE INGREDIENT	6M3P64V0NC	1
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	1
NASTURTIUM OFFICINALE FLOWERING TOP	INACTIVE INGREDIENT	W1N2U8I64G	1
PINE NEEDLE OIL (PINUS SYLVESTRIS)	INACTIVE INGREDIENT	5EXL5H740Y	1
POLYQUATERNIUM-28 (1100000 MW)	INACTIVE INGREDIENT	6M8B654MEQ	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	1
ROSEMARY	INACTIVE INGREDIENT	IJ67X351P9	1
TILIA CORDATA FLOWER	INACTIVE INGREDIENT	CFN6G1F6YK	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

DailyMed product names page 1 of 1 · 32 matching rows.

AT ONE WITH NATURE DRY AND ITCHY SCALP
PYRITHIONE ZINC
WATER
AMMONIUM LAURETH-2 SULFATE
AMMONIUM LAURYL SULFATE
COCO DIETHANOLAMIDE
DIHYDROGENATED TALLOW PHTHALIC ACID AMIDE
COCAMIDOPROPYL BETAINE
GLYCOL STEARATE
MENTHOL
MAGNESIUM ALUMINUM SILICATE
PROPYLENE GLYCOL
LAMIUM ALBUM
PINE NEEDLE OIL (PINUS SYLVESTRIS)
POLYQUATERNIUM-28 (1100000 MW)
ARGAN OIL
ARCTIUM LAPPA ROOT
ROSEMARY
HEDERA HELIX LEAF
ARNICA MONTANA FLOWER
NASTURTIUM OFFICINALE FLOWERING TOP
GARLIC
CALENDULA OFFICINALIS FLOWER
TILIA CORDATA FLOWER
CENTAUREA CYANUS FLOWER
CHAMAEMELUM NOBILE FLOWER
CHAMOMILE
HYPERICUM PERFORATUM
DMDM HYDANTOIN
CITRIC ACID MONOHYDRATE
EDETATE SODIUM
FD&C BLUE NO. 1

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
54602-758	54602-758-08, 54602-758-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 31 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
PYRITHIONE ZINC	R953O2RHZ5	ACTIB
WATER	059QF0KO0R	IACT
AMMONIUM LAURETH-2 SULFATE	698O4Z48G6	IACT
AMMONIUM LAURYL SULFATE	Q7AO2R1M0B	IACT
COCO DIETHANOLAMIDE	92005F972D	IACT
DIHYDROGENATED TALLOW PHTHALIC ACID AMIDE	1R81RPY10G	IACT
COCAMIDOPROPYL BETAINE	5OCF3O11KX	IACT
GLYCOL STEARATE	0324G66D0E	IACT
MENTHOL	L7T10EIP3A	IACT
MAGNESIUM ALUMINUM SILICATE	6M3P64V0NC	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
LAMIUM ALBUM	046Y1357I6	IACT
PINE NEEDLE OIL (PINUS SYLVESTRIS)	5EXL5H740Y	IACT
POLYQUATERNIUM-28 (1100000 MW)	6M8B654MEQ	IACT
ARGAN OIL	4V59G5UW9X	IACT
ARCTIUM LAPPA ROOT	597E9BI3Z3	IACT
ROSEMARY	IJ67X351P9	IACT
HEDERA HELIX LEAF	ZP9XFG71A7	IACT
ARNICA MONTANA FLOWER	OZ0E5Y15PZ	IACT
NASTURTIUM OFFICINALE FLOWERING TOP	W1N2U8I64G	IACT
GARLIC	V1V998DC17	IACT
CALENDULA OFFICINALIS FLOWER	P0M7O4Y7YD	IACT
TILIA CORDATA FLOWER	CFN6G1F6YK	IACT
CENTAUREA CYANUS FLOWER	QZ239038YC	IACT
CHAMAEMELUM NOBILE FLOWER	O2T154T6OG	IACT
CHAMOMILE	FGL3685T2X	IACT
HYPERICUM PERFORATUM	XK4IUX8MNB	IACT
DMDM HYDANTOIN	BYR0546TOW	IACT
CITRIC ACID MONOHYDRATE	2968PHW8QP	IACT
EDETATE SODIUM	MP1J8420LU	IACT
FD&C BLUE NO. 1	H3R47K3TBD	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 5 · 271 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / ORAL		22602 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE, EXTENDED RELEASE / ORAL		1 mg	Exact identifier — unii candidate 37 equally ranked IID candidates
EDETATE SODIUM	EDETATE SODIUM	MP1J8420LU	SOAP / TOPICAL	0.12 %w/w		Exact identifier — unii candidate 12 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
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, EXTENDED RELEASE / ORAL	9 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	TABLET / SUBLINGUAL		2 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SPRAY / SUBLINGUAL		36 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SHAMPOO / TOPICAL	0.75 %w/w		Exact identifier — unii candidate 37 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET, FILM COATED / ORAL	0.16 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE, LIQUID FILLED / ORAL	0.08 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	SYRUP / ORAL	7.5 mg/5ml		Exact identifier — unii candidate 24 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CREAM / TOPICAL	0.01 %w/w		Exact identifier — unii candidate 37 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET, DELAYED RELEASE / ORAL	0.01 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, SOLUTION / INTRAVENOUS		396 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
EDETATE SODIUM	EDETATE SODIUM	MP1J8420LU	TABLET / ORAL	5 mg		Exact identifier — unii candidate 12 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL / TRANSDERMAL		500 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATE	MAGNESIUM ALUMINUM SILICATE	6M3P64V0NC	SYRUP / ORAL	100 mg/1ml		Exact identifier — unii candidate 17 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / DENTAL	2 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / IONTOPHORESIS	0.02 %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
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUPPOSITORY / VAGINAL	252 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	CONCENTRATE / ORAL	5.3 mg/1ml		Exact identifier — unii candidate 88 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SOLUTION / DENTAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	CREAM / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	CREAM / TOPICAL		4 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION, CONCENTRATE / INTRAVENOUS	50.33 %w/v		Exact identifier — unii candidate 81 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	ELIXIR / ORAL	100 mg/5ml		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
MENTHOL	MENTHOL	L7T10EIP3A	SOLUTION / ORAL		3 mg	Exact identifier — unii candidate 24 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
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	LIQUID / RESPIRATORY (INHALATION)	10 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, DELAYED RELEASE / ORAL		36 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE, DELAYED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 37 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / RESPIRATORY (INHALATION)	25 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	DOUCHE / VAGINAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CLOTH / TOPICAL	0.03 mg/mg		Exact identifier — unii candidate 81 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
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL / RECTAL		3315 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	PASTE / DENTAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION / INTRAVENOUS		16624 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	FILM / SUBLINGUAL	0.07 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	LIQUID / ORAL		114 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION/ DROPS / OPHTHALMIC	0.05 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	PASTE / DENTAL	0.5 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / TOPICAL		4886 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION, CONCENTRATE / ORAL		2590 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / RECTAL		90400 mg	Exact identifier — unii candidate 81 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
MENTHOL	MENTHOL	L7T10EIP3A	SOLUTION, CONCENTRATE / ORAL	0.5 mg/1ml		Exact identifier — unii candidate 24 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATE	MAGNESIUM ALUMINUM SILICATE	6M3P64V0NC	LOTION / TOPICAL	1.5 %w/w		Exact identifier — unii candidate 17 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
AMMONIUM LAURYL SULFATE	AMMONIUM LAURYL SULFATE	Q7AO2R1M0B	EMULSION / TOPICAL	39.75 %w/w		Exact identifier — unii candidate 3 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CONCENTRATE / ORAL		7000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	JELLY / TOPICAL	20 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / AURICULAR (OTIC)	10 %w/v		Exact identifier — unii candidate 81 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
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE, COATED PELLETS / ORAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET / ORAL	27.53 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE, DELAYED RELEASE PELLETS / ORAL	0.01 mg		Exact identifier — unii candidate 37 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
3398bb40-df14-494e-9e1f-619629b94979			48da6e99-10d3-41fe-9e56-9dd98568dd7d	2012-12-27	Warnings	Exact identifier spl id: 3398bb40-df14-494e-9e1f-619629b94979 spl set id: 48da6e99-10d3-41fe-9e56-9dd98568dd7d

Reported adverse events (FAERS/openFDA)#

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