pseudoephedrine hydrochloride

Product NDC: 71205-197
11-digit product format: 712050197
Labeler code: 71205
Product ID: 71205-197_6236aedc-30e4-4415-b866-47a44a5da5b0
Type: HUMAN OTC DRUG
Nonproprietary name: Pseudoephedrine HCl
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Proficient Rx LP
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2008-10-17
Substance: PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength: 30 mg/1
Pharmacologic classes: Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: pseudoephedrine hydrochloride
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PSEUDOEPHEDRINE HYDROCHLORIDE	30 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
6V9V2RYJ8N	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1049160	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
a910320b-0585-40bd-928c-0406346281d0	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71205-197-24	pseudoephedrine hydrochloride	1 in 1 BLISTER PACK	TABLET, FILM COATED	1		3
71205-197-24	pseudoephedrine hydrochloride	24 in 1 CARTON	TABLET, FILM COATED	24		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71205-197-24	EA - Each	71205-197	ed63a6e9-e82f-41c9-ae8b-9e0df4f878b3	1	2019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71205-197	PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [PROFICIENT RX LP]	3	Current NDC, Legacy NDC, 2 package rows	20241025_a910320b-0585-40bd-928c-0406346281d0.zip

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 147 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
sinus pressure and pain pe	ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE	GOODSENSE	a7931e4c-8a5e-66e2-e053-2995a90af2a4	2024-10-18	Warnings	Exact identifier application number: M012
Sinus Severe	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	GoodSense	570ea130-6a99-446e-9f97-14fc95809006	2024-10-18	Warnings	Exact identifier application number: M012
Sinus and Headache	ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE	GOODSENSE	a14999e3-a9d9-0a1f-e053-2995a90af7b3	2024-10-18	Warnings	Exact identifier application number: M012
Allergy Multi Symptom	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE	GOODSENSE	a793000b-3ef9-5662-e053-2a95a90ad0da	2024-10-18	Warnings	Exact identifier application number: M012
Cold Multi-Symptom Daytime and Nighttime	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	GoodSense	37455f86-ab21-472b-9e80-40324699f3ca	2024-10-18	Warnings	Exact identifier application number: M012
Head Congestion Mucus PE	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	GOODSENSE	e3396a27-8643-71fa-e053-2a95a90a713d	2024-10-18	Warnings	Exact identifier application number: M012
Head Congestion Flu Severe PE	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	GOODSENSE	e3397f69-3267-ca0b-e053-2995a90a7db5	2024-10-18	Warnings	Exact identifier application number: M012
Cold and Head Congestion Severe	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	GoodSense	747512a2-3b6d-496b-ab80-819060314163	2024-10-18	Warnings	Exact identifier application number: M012
Allergy Multi Symptom	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE	AMERISOURCE BERGEN	9daf7f40-d9c5-4367-be41-894208358fc1	2024-10-18	Warnings	Exact identifier application number: M012
Cold Max	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	AmeriSource Bergen	608e6808-29e4-40bc-8496-24c092681a1b	2024-10-18	Warnings	Exact identifier application number: M012
Cold Flu Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	AmeriSource Bergen	665db127-ee04-46c4-bff0-e0fe9950c3e2	2024-10-18	Warnings	Exact identifier application number: M012
Cold Max Day and Night	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	AmeriSource Bergen	87a1cc06-9994-4fa9-8c64-e2ffdd33a2f8	2024-10-18	Warnings	Exact identifier application number: M012
Cold Head Congestion Severe	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	AmeriSource Bergen	604d7e53-4bfd-4cdd-aed2-b304ae82ce44	2024-10-18	Warnings	Exact identifier application number: M012
Allergy	DIPHENHYDRAMINE HYDROCHLORIDE	DISCOUNT DRUG MART	4d93a703-c905-4fb3-b772-11c207065d4d	2024-10-17	Warnings	Exact identifier application number: M012
Sinus Severe	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	DISCOUNT DRUG MART	62c35320-87b5-46e2-9f6f-cb0882bdb52e	2024-10-17	Warnings	Exact identifier application number: M012
Cold Max Nighttime	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	DISCOUNT DRUG MART	e3dcf6cf-373c-ea83-e053-2a95a90ae57a	2024-10-17	Warnings	Exact identifier application number: M012
Sinus Pressure plus Pain PE	ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE	DISCOUNT DRUG MART	a7e99dad-5918-6a90-e053-2a95a90a8803	2024-10-17	Warnings	Exact identifier application number: M012
SINUS AND HEADACHE	ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE	DISCOUNT DRUG MART	a7e99dad-5916-6a90-e053-2a95a90a8803	2024-10-17	Warnings	Exact identifier application number: M012
ALLERGY MULTISYMPTOM	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE	DISCOUNT DRUG MART	a7e9ab8e-2252-180d-e053-2a95a90a788f	2024-10-17	Warnings	Exact identifier application number: M012
COLD PLUS HEAD CONGESTION SEVERE	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	DISCOUNT DRUG MART	3430c7e4-e142-407e-bed5-358dd6bd10f7	2024-10-17	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6V9V2RYJ8N	PSEUDOEPHEDRINE HYDROCHLORIDE	345-78-8	PSEUDOEPHEDRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1049160	pseudoephedrine HCl 30 MG Oral Tablet	PSN	a910320b-0585-40bd-928c-0406346281d0	3
1049160	pseudoephedrine hydrochloride 30 MG Oral Tablet	SCD	a910320b-0585-40bd-928c-0406346281d0	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71205-197-24	71205019724	24 BLISTER PACK in 1 CARTON (71205-197-24) / 1 TABLET, FILM COATED in 1 BLISTER PACK	24 blister pack	2019-01-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Perrigo Pseudoephedrine Hydrochloride 30 mg Drug Facts	Proficient Rx LP	2024-10-01	HUMAN OTC DRUG LABEL	3