Nasal Decongestant

Product NDC: 21130-112
11-digit product format: 211300112
Labeler code: 21130
Product ID: 21130-112_b6ce85aa-3b57-4635-bc2b-8b9e8b1d6984
Type: HUMAN OTC DRUG
Nonproprietary name: Pseudoephedrine HCl
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Better Living Brands, LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 1981-08-25
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: Nasal Decongestant
Brand name suffix: Maximum Strength
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
9fe63ca6-3863-4175-9aec-ecd6ebbdb249	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
21130-112-08	Nasal DecongestantMaximum Strength	1 in 1 CARTON	TABLET, FILM COATED	1		15
21130-112-08	Nasal DecongestantMaximum Strength	24 in 1 BLISTER PACK	TABLET, FILM COATED	24		15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PSEUDOEPHEDRINE HYDROCHLORIDE	ACTIVE INGREDIENT	6V9V2RYJ8N	NASAL DECONGESTANT MAXIMUM STRENGTH (PSEUDOEPHEDRINE HCL 30 MG) TABLET, FILM COATED [SAFEWAY]	2
PSEUDOEPHEDRINE	ACTIVE MOIETY	7CUC9DDI9F	NASAL DECONGESTANT MAXIMUM STRENGTH (PSEUDOEPHEDRINE HCL 30 MG) TABLET, FILM COATED [SAFEWAY]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	NASAL DECONGESTANT MAXIMUM STRENGTH (PSEUDOEPHEDRINE HCL 30 MG) TABLET, FILM COATED [SAFEWAY]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	NASAL DECONGESTANT MAXIMUM STRENGTH (PSEUDOEPHEDRINE HCL 30 MG) TABLET, FILM COATED [SAFEWAY]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	NASAL DECONGESTANT MAXIMUM STRENGTH (PSEUDOEPHEDRINE HCL 30 MG) TABLET, FILM COATED [SAFEWAY]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	NASAL DECONGESTANT MAXIMUM STRENGTH (PSEUDOEPHEDRINE HCL 30 MG) TABLET, FILM COATED [SAFEWAY]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	NASAL DECONGESTANT MAXIMUM STRENGTH (PSEUDOEPHEDRINE HCL 30 MG) TABLET, FILM COATED [SAFEWAY]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NASAL DECONGESTANT MAXIMUM STRENGTH (PSEUDOEPHEDRINE HCL 30 MG) TABLET, FILM COATED [SAFEWAY]	2
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	NASAL DECONGESTANT MAXIMUM STRENGTH (PSEUDOEPHEDRINE HCL 30 MG) TABLET, FILM COATED [SAFEWAY]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	NASAL DECONGESTANT MAXIMUM STRENGTH (PSEUDOEPHEDRINE HCL 30 MG) TABLET, FILM COATED [SAFEWAY]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NASAL DECONGESTANT MAXIMUM STRENGTH (PSEUDOEPHEDRINE HCL 30 MG) TABLET, FILM COATED [SAFEWAY]	2
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	NASAL DECONGESTANT MAXIMUM STRENGTH (PSEUDOEPHEDRINE HCL 30 MG) TABLET, FILM COATED [SAFEWAY]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21130-112	NASAL DECONGESTANT MAXIMUM STRENGTH (PSEUDOEPHEDRINE HCL) TABLET, FILM COATED [BETTER LIVING BRANDS, LLC]	14	Current NDC, Legacy NDC, 2 package rows	20250110_9fe63ca6-3863-4175-9aec-ecd6ebbdb249.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 93 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
VANACOF DM	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	GM Pharmaceuticals, INC	2ed699f2-d004-4fa9-8042-6c85a9ff69b6	2025-11-03	Warnings	Exact identifier application number: M012
Geri Dryl	DIPHENHYDRAMINE HCL	VERITYRX, LLC	42a05f69-0599-5571-e063-6394a90a37d3	2025-11-02	Warnings	Exact identifier application number: M012
M-Dryl	DIPHENHYDRAMINE HYDROCHLORIDE	VERITYRX, LLC	42a0e577-a1b6-2c16-e063-6294a90af8e3	2025-11-02	Warnings	Exact identifier application number: M012
Severe Sinus Congestion and Pain	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE	Shield Pharmaceuticals Corp	c296efd0-5030-4a26-a9b0-e66423d995dc	2025-10-31	Warnings	Exact identifier application number: M012
Daytime Cold and Flu Max Maximum Strength Softgels	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Topco Associates, LLC	f7ebe482-cb22-4517-8463-3432cf60071d	2025-10-31	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu Max Softgels	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Topco Associates, LLC	787bff76-0ee2-4e7e-b908-876e4a3e3bfc	2025-10-31	Warnings	Exact identifier application number: M012
Honey Lemon Cough Drops	MENTHOL	Trader Joe's Company	647dadae-f37a-8399-e053-2991aa0aedb3	2025-10-31	Warnings	Exact identifier application number: M012
Family Care Saline	SODIUM CHLORIDE	United Exchange Corp.	06737393-d4ae-3e7b-e063-6394a90ac19f	2025-10-31	Warnings	Exact identifier application number: M012
QUALITY CHOICE Maximum Strength Daytime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Chain Drug Marketing Association, Inc.	40416ff5-06e1-97dd-e063-6394a90a2046	2025-10-30	Warnings	Exact identifier application number: M012
Robitussin Maximum Strength Nighttime Cough DM	DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Haleon US Holdings LLC	44feee2f-25bc-48d4-8e13-db1d9daaaa90	2025-10-30	Warnings	Exact identifier application number: M012
Robitussin Day and Night Cough Relief DM Max	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATE	Haleon US Holdings LLC	b3d02c91-8f79-4eb4-a378-1072474c572c	2025-10-30	Warnings	Exact identifier application number: M012
ROBITUSSIN MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM	DEXTROMETHORPHAN HBR, GUAIFENESIN	Haleon US Holdings LLC	f1d022dd-c2ca-497f-87d5-9ef3e20e8ea7	2025-10-30	Warnings	Exact identifier application number: M012
Endal	TRIPROLIDINE HCL, DEXTROMETHORPHAN HBR	Poly Pharmaceuticals, Inc.	fc5401e2-ed65-72e7-e053-6294a90a81f3	2025-10-30	Warnings	Exact identifier application number: M012
daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Publix Super Markets Inc	c7cef266-46fc-49ab-a2e7-54fc56298659	2025-10-30	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	SAM'S WEST INC	16592ad7-b7cb-0837-e063-6394a90ae059	2025-10-29	Warnings	Exact identifier application number: M012
Maximum Strength Severe Congestion and Cough	DEXTROMETHORPHAN HBR, GUAIFENESIN, AND PHENYLEPHRINE HCL	SAFEWAY	013b94a1-26c7-4371-981a-d1b9d7fd1c98	2025-10-29	Warnings	Exact identifier application number: M012
Better Living	PHENYLEPHRINE HYDROCHLORIDE	BETTER LIVING BRANDS LLC	aea0db7f-e01a-4d8e-9c20-4a5ef4a905d1	2025-10-29	Warnings	Exact identifier application number: M012
AXIM DayTime - Night Time 72 Softgels	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	VIVUNT PHARMA LLC	de9eb2d5-ba51-4637-e053-2995a90a0451	2025-10-29	Warnings	Exact identifier application number: M012
Dollar General Vapor Steam	CAMPHOR (SYNTHETIC)	DOLGENCORP, LLC	86d0f3ac-1359-c2f9-e053-2a91aa0a35d0	2025-10-29	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	Strategic Sourcing Services LLC	5d628b09-c257-4369-8ddb-47554d83c0d8	2025-10-29	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	9fe63ca6-3863-4175-9aec-ecd6ebbdb249	15
1049160	pseudoephedrine hydrochloride 30 MG Oral Tablet	SCD	9fe63ca6-3863-4175-9aec-ecd6ebbdb249	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
21130-112-08	21130011208	1 BLISTER PACK in 1 CARTON (21130-112-08) / 24 TABLET, FILM COATED in 1 BLISTER PACK	1 blister pack	1981-08-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Signature Select 44-112	Better Living Brands, LLC \| LNK International, Inc.	2026-01-19	HUMAN OTC DRUG LABEL	15