signature care 12 hour cough relief

Product NDC: 21130-012
11-digit product format: 211300012
Labeler code: 21130
Product ID: 21130-012_2deea3df-643c-4740-9e6b-79cb51319c8a
Type: HUMAN OTC DRUG
Nonproprietary name: dextromethorphan polistirex
Dosage form: SUSPENSION
Route: ORAL
Labeler: Safeway
Application: ANDA091135
Marketing category: ANDA
Marketing start: 2015-09-08
Substance: DEXTROMETHORPHAN HYDROBROMIDE
Active strength: 30 mg/5mL
Pharmacologic classes: Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Additional Listing Data#

Ingredient, Strength table
Ingredient	Strength
DEXTROMETHORPHAN HYDROBROMIDE	30 mg/5mL

Field, Values table
Field	Values
Unii	9D2RTI9KYH
Rxcui	1373045

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bf324df6-7127-7deb-def5-2681c136cd03	Product name	3	20250325
43a1ed49-eae2-4840-8075-cb4b33478540	Product name	1	20230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
a90f088a-9578-47a2-8f6e-0a9d32aafec6	Product name	1	20181030
f6c90bdc-1674-455a-aadd-1b1b59e5edeb	Product name	2	20181030
76633df9-0d59-4b88-03ed-21dee1b966f8	Product name	1	20140508
f1ec5c2f-d01e-a277-5826-c7eba86ed99b	Product name	1	20140508

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
21130-012-21	signature care 12 hour cough relief	89 mL in 1 BOTTLE	SUSPENSION	89		7
21130-012-21	signature care 12 hour cough relief	1 in 1 CARTON	SUSPENSION	1		7

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21130-012	SIGNATURE CARE 12 HOUR COUGH RELIEF (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [SAFEWAY]	7	Current NDC, Legacy NDC, 2 package rows	20230609_6f8d78f7-b3ec-43d1-a5a6-60a24e9ab8a8.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9D2RTI9KYH	DEXTROMETHORPHAN HYDROBROMIDE	6700-34-1	DEXTROMETHORPHAN HYDROBROMIDE

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1373045	dextromethorphan polistirex 30 MG in 5 mL 12HR Extended Release Oral Suspension	PSN	6f8d78f7-b3ec-43d1-a5a6-60a24e9ab8a8	7
1373045	12 HR dextromethorphan polistirex 6 MG/ML Extended Release Suspension	SCD	6f8d78f7-b3ec-43d1-a5a6-60a24e9ab8a8	7
1373045	dextromethorphan polistirex (dextromethorphan HBr 30 MG) per 5 ML 12 HR Extended Release Suspension	SY	6f8d78f7-b3ec-43d1-a5a6-60a24e9ab8a8	7
1373045	dextromethorphan polistirex 6 MG/ML 12 HR Extended Release Suspension	SY	6f8d78f7-b3ec-43d1-a5a6-60a24e9ab8a8	7

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
21130-012-21	21130001221	1 BOTTLE in 1 CARTON (21130-012-21) / 89 mL in 1 BOTTLE	1 bottle	2015-09-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Better Living Brands LLC 12 Hour Cough Relief Drug Facts	Safeway	2023-06-08	HUMAN OTC DRUG LABEL	7