Pseudoephedrine Hydrochloride

Manufacturer: Shopko Stores Operating Co., LLC | Ranbaxy Pharmaceuticals Inc. | Ohm Laboratories Inc.
Effective date: 2013-03-25
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:35:01

Label at a glance#

ProductPseudoephedrine Hydrochloride

Active ingredientPSEUDOEPHEDRINE HYDROCHLORIDE

Label structure9 sections

Indications and uses

Temporarily relieves nasal congestion due to: common cold hay fever upper respiratory allergies temporarily restores freer breathing through the nose promotes nasal and/or sinus drainage temporarily relieves sinus congestion and pressure

Dosage and administration

adults and children 12 years and older: 1 tablet every 12 hours; not more than 2 tablets in 24 hours children under 12 years: ask a doctor

Contacts and useful links#

PhoneLabel contact1-800-406-7984

Label contents#

Full prescribing information#

ACTIVE INGREDIENT (IN EACH TABLET)

OTC - ACTIVE INGREDIENT SECTION

Pseudoephedrine HCl USP, 120 mg

PURPOSE

OTC - PURPOSE SECTION

Nasal decongestant

USES

INDICATIONS & USAGE SECTION

Temporarily relieves nasal congestion due to:

common cold
hay fever
upper respiratory allergies
temporarily restores freer breathing through the nose
promotes nasal and/or sinus drainage
temporarily relieves sinus congestion and pressure

WARNINGS

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

heart disease
high blood pressure
diabetes
thyroid disease
trouble urinating due to an enlarged prostate gland

When using this product

OTC - WHEN USING SECTION

do not use more than directed

Stop use and ask a doctor if

OTC - STOP USE SECTION

symptoms do not get better within 7 days or occur with a fever
you get nervous, dizzy, or sleepless

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

Ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

adults and children 12 years and older: 1 tablet every 12 hours; not more than 2 tablets in 24 hours
children under 12 years: ask a doctor

OTHER INFORMATION

SPL UNCLASSIFIED SECTION

store at 59° to 77° F in a dry place
protect from light
TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Castor oil, colloidal silicon dioxide, hypromellose, microcrystalline cellulose, magnesium stearate, titanium dioxide

QUESTIONS?

OTC - QUESTIONS SECTION

Call 1-800-406-7984

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SHOPKO^®

Compare to the active ingredient of SUDAFED^®12 Hour

12 Hour, Non-Drowsy

Nasal Decongestant

Pseudoephedrine HCl Extended-Release Tablets, USP 120 mg

Long-Acting Nasal Decongestant

Nasal & Sinus Congestion Due to Colds & Allergies

Sinus Pressure

Maximum Strength

Manufactured by: Ohm Laboratories Inc.

5089484/R0212

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1049154	pseudoephedrine HCl 120 MG 12HR Extended Release Oral Tablet	PSN	1
1049154	12 HR pseudoephedrine hydrochloride 120 MG Extended Release Oral Tablet	SCD	1
1049154	pseudoephedrine HCl 120 MG 12 HR Extended Release Oral Tablet	SY	1

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
PSEUDOEPHEDRINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Data code	ITF	05089484		PSE.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
0fdb98e2-b951-a1ce-5715-2b187ba500ef	Product name	4	20170718
e974e22d-8688-7d92-1e87-40c1079e170c	Product name	3	20151125
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
30c51294-7ae9-8007-7de6-58222684a0be	Product name	1	20140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66	Product name	1	20140508
70a83adc-6047-bbea-5a08-dfd304aa47d2	Product name	1	20140508
858ce051-9941-aafc-8c7c-44a8e0227463	Product name	1	20140508
b893258d-0942-3d8a-3411-056ea0788ff5	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
37012-204-20	2020-01-31	C162847	48780-1	9d75b9d0-88b1-f424-e053-dadaa90a57ce	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
37012-204-20	Pseudoephedrine Hydrochloride	20 in 1 BLISTER PACK	TABLET, FILM COATED, EXTENDED RE	20		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
37012-204	PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [SHOPKO STORES OPERATING CO., LLC]	1	Legacy NDC, 1 package rows	20130325_ca6d7a50-3e73-4997-b79d-648a733bf856.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
PSEUDOEPHEDRINE HYDROCHLORIDE	ACTIVE INGREDIENT	6V9V2RYJ8N	1
PSEUDOEPHEDRINE	ACTIVE MOIETY	7CUC9DDI9F	1
CASTOR OIL	INACTIVE INGREDIENT	D5340Y2I9G	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	1
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	1

Products#

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

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

Pseudoephedrine Hydrochloride
PSEUDOEPHEDRINE
CASTOR OIL
COLLOIDAL SILICON DIOXIDE
HYPROMELLOSES
CELLULOSE, MICROCRYSTALLINE
MAGNESIUM STEARATE
TITANIUM DIOXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
37012-204	37012-204-20

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
Name	UNII	Kind
PSEUDOEPHEDRINE HYDROCHLORIDE	6V9V2RYJ8N	ACTIB
CASTOR OIL	D5340Y2I9G	IACT
COLLOIDAL SILICON DIOXIDE	ETJ7Z6XBU4	IACT
HYPROMELLOSES	3NXW29V3WO	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
TITANIUM DIOXIDE	15FIX9V2JP	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 4 · 199 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	SUSPENSION / OPHTHALMIC	0.5 %w/w		Exact identifier — unii candidate 27 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IMPLANT / INTRAVITREAL	1.66 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER, FOR SOLUTION / ORAL		280 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	RING / VAGINAL		2 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / NASAL		20 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	CREAM / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 27 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SHAMPOO, SUSPENSION / TOPICAL	3 %w/v		Exact identifier — unii candidate 40 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE / ORAL		72 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SYSTEM / TOPICAL		420 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / BUCCAL		3 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	FILM, SOLUBLE / ORAL		2 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	LOTION / TOPICAL	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
CASTOR OIL	CASTOR OIL	D5340Y2I9G	OINTMENT / TOPICAL	14.9 %w/w		Exact identifier — unii candidate 16 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, EXTENDED RELEASE / ORAL		5119 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	GEL / RECTAL		348 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	GRANULE, FOR SUSPENSION / ORAL		143 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED / ORAL		96 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, ORALLY DISINTEGRATING / ORAL		41 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, CHEWABLE / ORAL		127 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	SUSPENSION, EXTENDED RELEASE / ORAL		1120 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		53 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	CAPSULE, EXTENDED RELEASE / ORAL		1246 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	GUM, CHEWING / BUCCAL		182 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, ORALLY DISINTEGRATING / ORAL		68 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	POWDER / TOPICAL		104 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, LIQUID FILLED / ORAL		106 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		47 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, LIQUID FILLED / ORAL		12 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	GRANULE, FOR SUSPENSION / ORAL	1.7 mg		Exact identifier — unii candidate 27 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		11 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
CASTOR OIL	CASTOR OIL	D5340Y2I9G	GRANULE, FOR SUSPENSION / ORAL		128 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, DELAYED RELEASE PELLETS / ORAL		24 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, EXTENDED RELEASE / ORAL		90 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 27 equally ranked IID candidates
CASTOR OIL	CASTOR OIL	D5340Y2I9G	SPRAY / NASAL	NA		Exact identifier — unii candidate 16 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	FILM, SOLUBLE / BUCCAL		11 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	IMPLANT / INTRAVITREAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
CASTOR OIL	CASTOR OIL	D5340Y2I9G	TABLET, COATED / ORAL	0.9 mg		Exact identifier — unii candidate 16 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	POWDER, FOR SUSPENSION / ORAL		297 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		336 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	PASTE, DENTIFRICE / DENTAL	0.4 %w/w		Exact identifier — unii candidate 40 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, COATED / ORAL		3 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / SUBLINGUAL		10 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		144 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, DELAYED RELEASE / ORAL		40 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	SYSTEM / INTRAVITREAL	0.02 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, EXTENDED RELEASE / ORAL		67 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL		980 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, COATED / ORAL		58 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	SUSPENSION / ORAL		400 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	221 mg		Exact identifier — unii candidate 27 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / BUCCAL		18 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	CAPSULE / ORAL	256.4 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
CASTOR OIL	CASTOR OIL	D5340Y2I9G	INJECTION, SOLUTION / INTRAMUSCULAR		525 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE, DELAYED RELEASE / ORAL	3.2 mg		Exact identifier — unii candidate 49 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, CHEWABLE / ORAL		1725 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	WAFER / ORAL	66 mg		Exact identifier — unii candidate 39 equally ranked IID candidates

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A077442-001	PSEUDOEPHEDRINE HYDROCHLORIDE	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL			2005-09-28

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A077442-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2005-09-28	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A077442-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2005-09-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077442-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2005-09-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077442-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2005-09-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077442-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2005-09-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077442-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2005-09-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077442-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2005-09-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077442-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2005-09-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077442-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2005-09-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077442-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2005-09-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077442-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2005-09-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077442-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2005-09-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077442-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2005-09-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077442-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2005-09-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077442-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2005-09-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077442-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2005-09-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077442-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2005-09-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077442-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2005-09-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077442-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2005-09-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077442-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2005-09-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077442-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2005-09-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077442-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2005-09-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077442-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2005-09-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077442-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2005-09-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077442-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2005-09-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077442-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2005-09-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077442-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2005-09-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077442-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2005-09-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077442-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2005-09-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077442-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2005-09-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077442-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2005-09-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077442-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2005-09-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077442-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2005-09-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077442-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2005-09-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077442-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2005-09-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077442-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2005-09-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077442-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2005-09-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077442-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2005-09-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077442-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2005-09-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077442-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2005-09-28	`3a93d1ddd44b…`

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
de0f0d0a-d2aa-4580-bc53-3e26bfde12b5			ca6d7a50-3e73-4997-b79d-648a733bf856	2013-03-25	Warnings	Exact identifier spl id: de0f0d0a-d2aa-4580-bc53-3e26bfde12b5 spl set id: ca6d7a50-3e73-4997-b79d-648a733bf856

Reported adverse events (FAERS/openFDA)#

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