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 120 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AXIV DayTime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	VIVUNT PHARMA LLC	131b1f17-cd86-f9b3-e063-6294a90a3028	2025-02-12	Warnings	Exact identifier application number: M012
Maximum Strength Mucus Relief DM Max	DEXTROMETHORPHAN HBR, GUAIFENESIN	Topco Associates, LLC	17d0dbc7-c8c2-7917-e063-6394a90a42af	2025-02-12	Warnings	Exact identifier application number: M012
DAYTIME COLD AND FLU	DEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE	Kroger Company	bc00bbf8-52bb-fa75-e053-2a95a90a9406	2025-02-11	Warnings	Exact identifier application number: M012
Daytime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCI 325, 10, 5 MG SOFTGELS	TIME CAP LABORATORIES, INC.	fd24653e-c4fa-3c09-e053-6394a90aaa9e	2025-02-10	Warnings	Exact identifier application number: M012
Daytime Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCI, DOXYLAMINE SUCCINATE 325, 10/15, 5, 6.25 MG SOFTGELS	TIME CAP LABORATORIES INC.	fd81dd4b-9617-f4c1-e053-6394a90a5e72	2025-02-10	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	DOLGENCORP, LLC	be2207b7-b8f8-7fba-e053-2a95a90abd16	2025-02-10	Warnings	Exact identifier application number: M012
NIGHTTIME COLD AND FLU	DEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, DOXYLAMINE SUCCINATE	Kroger Company	bc0115a3-5322-855d-e053-2995a90aba27	2025-02-10	Warnings	Exact identifier application number: M012
Day time high blood pressure cold and flu	ACETAMINOPHEN DEXTROMETHORPHAN HBR	Camber Consumer Care	09fbd872-0970-4864-9308-4a7b85983920	2025-02-10	Warnings	Exact identifier application number: M012
Cough Drops	MENTHOL	The Kroger CO	f05e11ce-c908-acbc-e053-2a95a90a584e	2025-02-09	Warnings	Exact identifier application number: M012
Cough Drops	MENTHOL	The Kroger CO	f035c499-cda6-fadf-e053-2995a90af457	2025-02-09	Warnings	Exact identifier application number: M012
Cough Drops	MENTHOL	The Kroger CO	f6d977ce-bbca-f1cc-e053-6394a90acc96	2025-02-09	Warnings	Exact identifier application number: M012
Cough Drops	MENTHOL	The Kroger CO	f6da36d3-496d-2336-e053-6394a90a0f83	2025-02-09	Warnings	Exact identifier application number: M012
Cough Drops	MENTHOL	The Kroger CO	f6da2e02-42c7-1ede-e053-6394a90aff5f	2025-02-09	Warnings	Exact identifier application number: M012
MUCOSA DM	GUAIFENESIN DEXTROMETHORPHAN	TIME CAP LABORATORIES, INC.	62c1f4aa-6571-414c-9a58-31e107b7db97	2025-02-08	Warnings	Exact identifier application number: M012
Childrens Cough and Chest Congestion	DEXTROMETHORPHAN HBR, GUAIFENESIN	Genexa Inc.	2d95d5a4-34dc-e195-e063-6394a90a39da	2025-02-07	Warnings	Exact identifier application number: M012
Halls Sugar Free Honey Lemon	MENTHOL	Mondelez Global LLC	5d56ccd2-1c28-4750-9454-44809091ad2f	2025-02-05	Warnings	Exact identifier application number: M012
SanaTos Mucus Relief Cold Toddlers	DEXTROMETHORPHAN HBR, GUAIFENESIN	Pharmadel LLC	60672feb-1421-651e-e053-2a91aa0af41d	2025-02-04	Warnings	Exact identifier application number: M012
SofSkin Vaporizing Chest Rub and Cough Suppressant	CAMPHOR, MENTHOL, EUCALYPTUS OIL	Viny Health and Beauty Inc	34626cf5-64fc-15c0-e063-6294a90aa310	2025-02-04	Warnings	Exact identifier application number: M012
Pain Reliever PM	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	CVS PHARMACY, INC	17922df7-7867-4300-bd99-55aee7b60606	2025-02-04	Warnings	Exact identifier application number: M012
No Drip Nasal Mist	OXYMETAZOLINE SPRAY	CVS Health	f4b8ff54-47b5-4d18-bf4e-b101abb22a24	2025-02-03	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