Aspirin EC Tablets, 81 mg

Manufacturer: Aphena Pharma Solutions - Tennessee, LLC
Effective date: 2013-06-05
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:35:38

Label at a glance#

ProductAspirin EC

Active ingredientASPIRIN

Label structure12 sections

Indications and uses

temporarily relieves minor aches and pains for other uses, see your doctor, but do not use for more than 10 days without consulting your doctor because serious side effects may occur

Dosage and administration

drink a full glass of water with each dose adults and children 12 years and over: take 4 to 8 tablets every 4 hours not to exceed 48 tablets in 24 hours unless directed by a doctor children under 12 years: consult a doctor

Storage and handling

store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F) use by expiration date on package

Contacts and useful links#

PhoneLabel contact1-888-838-2872

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Aspirin 81 mg (NSAID¹)

nonsteroidal anti-inflammatory drug

Purpose

OTC - PURPOSE SECTION

Pain reliever

Uses

INDICATIONS & USAGE SECTION

temporarily relieves minor aches and pains
for other uses, see your doctor, but do not use for more than 10 days without consulting your doctor because serious side effects may occur

Warnings

WARNINGS SECTION

Reye's syndrome

SPL UNCLASSIFIED SECTION

Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

Allergy alert

SPL UNCLASSIFIED SECTION

Aspirin may cause a severe allergic reaction, which may include:

hives
facial swelling
shock
asthma (wheezing)

Stomach bleeding warning

SPL UNCLASSIFIED SECTION

This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

are age 60 or older
have had stomach ulcers or bleeding problems
take a blood thinning (anticoagulant) or steroid drug
take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
have 3 or more alcoholic drinks every day while using this product
take more or for a longer time than directed

Do not use

OTC - DO NOT USE SECTION

if you are allergic to aspirin or any other pain reliever/fever reducer

OTC - ASK DOCTOR SECTION

Ask a doctor before use if

stomach bleeding warning applies to you
you have a history of stomach problems, such as heartburn
you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
you are taking a diuretic
you have asthma
you have not been drinking fluids
you have lost a lot of fluid due to vomiting or diarrhea

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are

taking a prescription drug for diabetes, gout, or arthritis
taking any other drug
under a doctor's care for any serious condition

OTC - STOP USE SECTION

Stop use and ask a doctor if

you experience any of the following signs of stomach bleeding:
- feel faint
- have bloody or black stools
- vomit blood
- have stomach pain that does not get better
pain gets worse or lasts more than 10 days
fever gets worse or lasts more than 3 days
redness or swelling is present in the painful area
any new symptoms appear
ringing in the ears or a loss of hearing occurs

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

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.

Directions

DOSAGE & ADMINISTRATION SECTION

drink a full glass of water with each dose
adults and children 12 years and over: take 4 to 8 tablets every 4 hours not to exceed 48 tablets in 24 hours unless directed by a doctor
children under 12 years: consult a doctor

Other information

STORAGE AND HANDLING SECTION

store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
use by expiration date on package

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous lactose, carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10 aluminum lake, iron oxide ochre, methacrylic acid copolymer, microcrystalline cellulose, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate

Questions?

OTC - QUESTIONS SECTION

call 1-888-838-2872, weekdays, 8 AM-5 PM ET

SPL UNCLASSIFIED SECTION

Repackaged by Aphena Pharma Solutions - TN.
See Repackaging Information for available configurations.

Aphena Pharma Solutions - TN

Distributed by: GOLDLINE LABORATORIES, INC., Sellersville, PA 18960

Dist. 1993 0711REV 89 387R

TAMPER-EVIDENT: DO NOT USE THIS PRODUCT IF THE IMPRINTED FOIL SEAL OVER THE MOUTH OF THE BOTTLE IS CUT, TORN, BROKEN OR MISSING

** This product is not manufactured or distributed by Bayer HealthCare LLC, owner of the registered trademark Bayer^® Low Dose.

Repackaging Information

SPL UNCLASSIFIED SECTION

Please reference the Product Characteristics section listed below for a description of individual tablets or capsules. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

Count	81mg
30	67544-524-30
90	67544-524-60

Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

Repackaged by:
Aphena Pharma Solutions - TN
Cookeville, TN 38506

20130605AW

PRINCIPAL DISPLAY PANEL - 81mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 67544-524 - Aspirin 81mg
Bottle Label 81mg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
308416	aspirin 81 MG Delayed Release Oral Tablet	PSN	1
308416	aspirin 81 MG Delayed Release Oral Tablet	SCD	1
308416	ASA 81 MG Delayed Release Oral Tablet	SY	1
308416	aspirin 81 MG Enteric Coated Oral Tablet	SY	1

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
ASPIRIN Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20191108

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d7724692-1155-4cc8-a415-22f5fc4aec35	Product name	6	20220216
bde672ba-4805-28d0-1986-73543d41b412	Product name	2	20210201
f212291f-05fe-9603-fc7e-bd73e38ce1e6	Product name	2	20161129
ade821ba-260a-47e2-bd89-743e27ac9906	Product name	1	20161121
182f9ab4-4ab5-c449-200f-87ce2ce8e550	Product name	2	20151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657	Product name	1	20150929
2a21311a-89e2-0e83-2ebd-117f9798b2b2	Product name	1	20140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94e	Product name	1	20140508
96c2be53-8e44-452d-56a2-d255b2f1af2d	Product name	1	20140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
67544-524-30	2020-01-31	C162847	48780-1	9d75b9d0-2fad-f424-e053-dadaa90a57ce	Aspirin EC Tablets, 81 mg
67544-524-60	2020-01-31	C162847	48780-1	9d75b9d0-2fad-f424-e053-dadaa90a57ce	Aspirin EC Tablets, 81 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67544-524-30	Aspirin EC	30 in 1 BOTTLE, PLASTIC	TABLET, COATED	30		1
67544-524-60	Aspirin EC	90 in 1 BOTTLE, PLASTIC	TABLET, COATED	90		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67544-524	ASPIRIN EC (ASPIRIN) TABLET, COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1	Legacy NDC, 2 package rows	20130606_343539cf-038d-4b07-aa64-bddd3731e7e2.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67544-524-30	EA - Each	67544-524	0c60be51-d5f5-44d1-a0f5-6f2c1c415079	1	2013-07-02
67544-524-60	EA - Each	67544-524	59be968c-be9c-4086-a7d0-9fadcab999a8	1	2013-07-02
0182-1061-05	EA - Each	0182-1061	4f2f3142-2b97-425f-940f-039cfd175a06	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
ASPIRIN	ACTIVE INGREDIENT	R16CO5Y76E	1
ASPIRIN	ACTIVE MOIETY	R16CO5Y76E	1
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	1
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	1
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	1

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

Aspirin EC
Aspirin
ANHYDROUS LACTOSE
CARNAUBA WAX
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
D&C YELLOW NO. 10
ALUMINUM OXIDE
FERRIC OXIDE YELLOW
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
CELLULOSE, MICROCRYSTALLINE
POLYSORBATE 80
SODIUM HYDROXIDE
SODIUM LAURYL SULFATE
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
67544-524	67544-524-30, 67544-524-60
0182-1061

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ASPIRIN	R16CO5Y76E	ACTIB
ANHYDROUS LACTOSE	3SY5LH9PMK	IACT
CARNAUBA WAX	R12CBM0EIZ	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
D&C YELLOW NO. 10	35SW5USQ3G	IACT
ALUMINUM OXIDE	LMI26O6933	IACT
FERRIC OXIDE YELLOW	EX438O2MRT	IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	NX76LV5T8J	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
POLYSORBATE 80	6OZP39ZG8H	IACT
SODIUM HYDROXIDE	55X04QC32I	IACT
SODIUM LAURYL SULFATE	368GB5141J	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
TRIETHYL CITRATE	8Z96QXD6UM	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 10 · 585 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	GEL / OPHTHALMIC		6 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / URETHRAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	GEL / DENTAL	NA		Exact identifier — unii candidate 31 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / EXTRACORPOREAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	EMULSION / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 174 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / BUCCAL		3 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, SUSPENSION / INTRAVENOUS	0.5 %w/v		Exact identifier — unii candidate 78 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SOLUTION / INTRAVENOUS		78 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	INSERT / VAGINAL		15 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, SUSPENSION / INTRA-ARTICULAR		4 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	PELLET / ORAL		1140 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	SHAMPOO / TOPICAL	NA		Exact identifier — unii candidate 31 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / INTRAVASCULAR	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRACARDIAC	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
TRIETHYL CITRATE	TRIETHYL CITRATE	8Z96QXD6UM	CAPSULE, DELAYED RELEASE / ORAL		70 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SUSPENSION / RESPIRATORY (INHALATION)		1 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	CAPSULE, EXTENDED RELEASE / ORAL		166 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	POWDER, FOR SUSPENSION / ORAL		9 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	CAPSULE, EXTENDED RELEASE / ORAL		3 mg	Exact identifier — unii candidate 31 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CAPSULE, COATED PELLETS / ORAL	2 mg		Exact identifier — unii candidate 78 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	CAPSULE, DELAYED RELEASE / ORAL		420 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	CAPSULE / ORAL		2169 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET / ORAL		736 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET, FOR SUSPENSION / ORAL		1875 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, EMULSION / INTRAVENOUS	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	CREAM / VAGINAL		12 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	POWDER, FOR SUSPENSION / ORAL		735 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE / ORAL	5000 mg		Exact identifier — unii candidate 49 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRA-ARTERIAL	176 mg		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRALESIONAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	JELLY / TOPICAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET, EFFERVESCENT / ORAL	1.5 mg		Exact identifier — unii candidate 42 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	CAPSULE, DELAYED RELEASE PELLETS / ORAL		127 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / INTRAVENOUS	2.78 %w/v		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	TABLET, FILM COATED / ORAL		8 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	FILM, EXTENDED RELEASE / TRANSDERMAL	0.85 mg		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	GEL / VAGINAL		20 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SUSPENSION / ORAL		113 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SUSPENSION/ DROPS / AURICULAR (OTIC)	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	CAPSULE / ORAL		729 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SYSTEM / TOPICAL		28 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET, DELAYED RELEASE / ORAL		7 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE, DELAYED RELEASE / ORAL	3.2 mg		Exact identifier — unii candidate 49 equally ranked IID candidates
ANHYDROUS LACTOSE	ANHYDROUS LACTOSE	3SY5LH9PMK	TABLET, ORALLY DISINTEGRATING / ORAL		410 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
CARNAUBA WAX	CARNAUBA WAX	R12CBM0EIZ	TABLET, DELAYED RELEASE / ORAL	230 mg		Exact identifier — unii candidate 11 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	CAPSULE, DELAYED RELEASE / ORAL		72 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET, ORALLY DISINTEGRATING / ORAL		16 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
TRIETHYL CITRATE	TRIETHYL CITRATE	8Z96QXD6UM	TABLET, FILM COATED / ORAL		3 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRAMUSCULAR	176 mg		Exact identifier — unii candidate 174 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	PELLET / ORAL		34 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	OINTMENT, AUGMENTED / TOPICAL	0.11 %w/w		Exact identifier — unii candidate 174 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE, FOR SUSPENSION / ORAL		200 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET / ORAL		233 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	SUPPOSITORY / RECTAL	14 mg		Exact identifier — unii candidate 49 equally ranked IID candidates
ANHYDROUS LACTOSE	ANHYDROUS LACTOSE	3SY5LH9PMK	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		375 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SUSPENSION / ORAL	400 mg		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		27 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	POWDER / INTRAVENOUS	ADJ PH		Exact identifier — unii candidate 174 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
4022ec92-1e3c-40a7-9a23-e28f40e79a12			343539cf-038d-4b07-aa64-bddd3731e7e2	2013-06-05	Warnings	Exact identifier spl id: 4022ec92-1e3c-40a7-9a23-e28f40e79a12 spl set id: 343539cf-038d-4b07-aa64-bddd3731e7e2

Reported adverse events (FAERS/openFDA)#

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