ACTINEL

Product NDC: 63102-101
11-digit product format: 631020101
Labeler code: 63102
Product ID: 63102-101_11f69bba-6b7f-4876-a8ba-123264408164
Type: HUMAN OTC DRUG
Nonproprietary name: Dextromethorphan HBr,Guaifenesin,Pseudoephedrine HCl
Dosage form: SOLUTION
Route: ORAL
Labeler: ACTIPHARMA, LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2014-09-24
Substance: DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength: 15; 200; 30 mg/5mL; mg/5mL; mg/5mL
Pharmacologic classes: Adrenergic alpha-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [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: ACTINEL
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXTROMETHORPHAN HYDROBROMIDE	15 mg/5mL
GUAIFENESIN	200 mg/5mL
PSEUDOEPHEDRINE HYDROCHLORIDE	30 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9D2RTI9KYH	Internal UNII lookup
495W7451VQ	Internal UNII lookup
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
1098227	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
db0cb6ae-0a4d-4232-805a-f3f3a058261f	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
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
4fe95224-f543-4dbb-9445-8cca122b48c8	Product name	1	20150609
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
106ff02a-57e1-4c4c-a307-fd582ff4e311	Product name	1	20150212
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
63102-101-16	2023-10-18	C162847	48780-1	0191ceaa-706a-198a-e063-dbdaa90aec3e	ACTINEL ®
63102-101-16	2023-07-28	C162847	48780-1	0191ceaa-706a-198a-e063-dbdaa90aec3e	ACTINEL ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63102-101-16	ACTINEL	474 mL in 1 BOTTLE	SOLUTION	474		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63102-101-16	ML - Milliliter	63102-101	f2212955-c84c-44f7-9dc8-cc54a6f7145b	1	2015-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	ACTINEL (DEXTROMETHORPHAN HBR,GUAIFENESIN,PSEUDOEPHEDRINE HCL) SOLUTION [ACTIPHARMA, INC]	1
GUAIFENESIN	ACTIVE INGREDIENT	495W7451VQ	ACTINEL (DEXTROMETHORPHAN HBR,GUAIFENESIN,PSEUDOEPHEDRINE HCL) SOLUTION [ACTIPHARMA, INC]	1
PSEUDOEPHEDRINE HYDROCHLORIDE	ACTIVE INGREDIENT	6V9V2RYJ8N	ACTINEL (DEXTROMETHORPHAN HBR,GUAIFENESIN,PSEUDOEPHEDRINE HCL) SOLUTION [ACTIPHARMA, INC]	1
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	ACTINEL (DEXTROMETHORPHAN HBR,GUAIFENESIN,PSEUDOEPHEDRINE HCL) SOLUTION [ACTIPHARMA, INC]	1
GUAIFENESIN	ACTIVE MOIETY	495W7451VQ	ACTINEL (DEXTROMETHORPHAN HBR,GUAIFENESIN,PSEUDOEPHEDRINE HCL) SOLUTION [ACTIPHARMA, INC]	1
PSEUDOEPHEDRINE	ACTIVE MOIETY	7CUC9DDI9F	ACTINEL (DEXTROMETHORPHAN HBR,GUAIFENESIN,PSEUDOEPHEDRINE HCL) SOLUTION [ACTIPHARMA, INC]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	ACTINEL (DEXTROMETHORPHAN HBR,GUAIFENESIN,PSEUDOEPHEDRINE HCL) SOLUTION [ACTIPHARMA, INC]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	ACTINEL (DEXTROMETHORPHAN HBR,GUAIFENESIN,PSEUDOEPHEDRINE HCL) SOLUTION [ACTIPHARMA, INC]	1
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	ACTINEL (DEXTROMETHORPHAN HBR,GUAIFENESIN,PSEUDOEPHEDRINE HCL) SOLUTION [ACTIPHARMA, INC]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	ACTINEL (DEXTROMETHORPHAN HBR,GUAIFENESIN,PSEUDOEPHEDRINE HCL) SOLUTION [ACTIPHARMA, INC]	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	ACTINEL (DEXTROMETHORPHAN HBR,GUAIFENESIN,PSEUDOEPHEDRINE HCL) SOLUTION [ACTIPHARMA, INC]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	ACTINEL (DEXTROMETHORPHAN HBR,GUAIFENESIN,PSEUDOEPHEDRINE HCL) SOLUTION [ACTIPHARMA, INC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	ACTINEL (DEXTROMETHORPHAN HBR,GUAIFENESIN,PSEUDOEPHEDRINE HCL) SOLUTION [ACTIPHARMA, INC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63102-101	ACTINEL (DEXTROMETHORPHAN HBR,GUAIFENESIN,PSEUDOEPHEDRINE HCL) SOLUTION [ACTIPHARMA, LLC]	5	Current NDC, Legacy NDC, 1 package rows	20240814_db0cb6ae-0a4d-4232-805a-f3f3a058261f.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 170 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
THERAFLU NIGHTTIME SEVERE COLD AND COUGH	ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Haleon US Holdings LLC	5f7f6f70-0f36-4541-89f2-d953259cdb1e	2024-01-28	Warnings	Exact identifier application number: M012
RESFRIOL D	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	OPMX LLC	0e9c96b9-41ac-0faf-e063-6294a90a8ab5	2024-01-26	Warnings	Exact identifier application number: M012
Allergy Relief	ALLERGY RELIEF	Good Sense	bb709377-7bb3-4931-a2b6-2443aee07c12	2024-01-26	Warnings	Exact identifier application number: M012
Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu Nighttime	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	Haleon US Holdings LLC	721bfee2-0d3d-4d8b-beee-1ea83064d1c8	2024-01-23	Warnings	Exact identifier application number: M012
Sugar Free Cough Drops Honey Lemon	MENTHOL	Cardinal Health 110, Inc.	fe90dc33-2815-8296-e053-6294a90ac1df	2024-01-19	Warnings	Exact identifier application number: M012
Sugar Free Cough Drops	MENTHOL	Cardinal Health 110, Inc.	fe91543e-a798-6399-e053-6394a90af5e5	2024-01-19	Warnings	Exact identifier application number: M012
Sugar Free Cough Drops Black Cherry	MENTHOL	Cardinal Health 110, Inc.	fe90cf63-d286-fa5e-e053-6394a90a7759	2024-01-19	Warnings	Exact identifier application number: M012
Cough Drops Menthol Honey Lemon	COUGH DROPS MENTHOL	Cardinal Health 110, Inc.	fe5b3f6d-2a2d-f322-e053-6394a90aba04	2024-01-19	Warnings	Exact identifier application number: M012
Cough Drops Menthol	MENTHOL COUGH DROPS	Cardinal Health 110, Inc.	fe5b557e-a689-a32c-e053-6294a90aadbd	2024-01-19	Warnings	Exact identifier application number: M012
Cough Drops Cherry	CHERRY FLAVOR COUGH DROPS	Cardinal Health 110, Inc.	fe5b5e57-1368-c62b-e053-6294a90ae82c	2024-01-19	Warnings	Exact identifier application number: M012
Leader Zinc Oxide	ZINC OXIDE	Cardinal Health 110,Inc.	4d675dfd-6ea9-4aa7-a4ff-bb84f87ff7d1	2024-01-18	Warnings	Exact identifier application number: M012
Cough and Congestion DM Sugar Free	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Best Choice (Valu Merchandisers Company)	4656e60e-4733-45c1-bf55-d156e45085c6	2024-01-17	Warnings	Exact identifier application number: M012
Nasal Decongestant	PSEUDOEPHEDRINE HCL	Rugby Laboratories	775f97c0-6f82-49a8-82ac-f1a73920c3ec	2024-01-11	Warnings	Exact identifier application number: M012
SinuFrin NeilMed	OXYMETAZOLINE HYDROCHLORIDE	NeilMed Pharmaceuticals Inc	f9ec6ac3-1e00-4e97-97c8-b2cd66a752ae	2024-01-11	Warnings	Exact identifier application number: M012
SinuFrin Plus NeilMed	OXYMETAZOLINE HYDROCHLORIDE	NeilMed Pharmaceuticals, Inc.	99afe6a6-1350-49c6-9347-b7e531e35925	2024-01-11	Warnings	Exact identifier application number: M012
Childrens Tukol Multi-Symptom Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Genomma Lab USA, Inc.	85fe6f0f-41c8-44d3-a34a-355938da5f72	2024-01-11	Warnings	Exact identifier application number: M012
Allergy Relief Diphenhydramine HCl	DIPHENHYDRAMINE HYDROCHLORIDE	Cardinal Health 110, LLC. DBA Leader	ad437177-08eb-4811-883f-ac543d5bc58c	2024-01-11	Warnings	Exact identifier application number: M012
Allergy Antihistamine	DIPHENHYDRAMINE HYDROCHLORIDE	KROGER COMPANY	af5053d8-ba02-4cdf-877f-8c1e368dafe0	2024-01-10	Warnings	Exact identifier application number: M012
HISTEX	TRIPROLIDINE HYDROCHLORIDE	Allegis Pharmaceuticals, LLC	cc466d33-cf3e-4f1c-a794-6d3d79903adf	2024-01-08	Warnings	Exact identifier application number: M012
HISTEX-DM	DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE	Allegis Pharmaceuticals, LLC	836d062c-29f0-4fd7-b65c-771a3bbd52c4	2024-01-08	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9D2RTI9KYH	DEXTROMETHORPHAN HYDROBROMIDE	6700-34-1	DEXTROMETHORPHAN HYDROBROMIDE
495W7451VQ	GUAIFENESIN	93-14-1	GUAIFENESIN
6V9V2RYJ8N	PSEUDOEPHEDRINE HYDROCHLORIDE	345-78-8	PSEUDOEPHEDRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1098227	dextromethorphan HBr 15 MG / guaiFENesin 200 MG / pseudoephedrine HCl 30 MG in 5 mL Oral Solution	PSN	db0cb6ae-0a4d-4232-805a-f3f3a058261f	6
1098227	dextromethorphan hydrobromide 3 MG/ML / guaifenesin 40 MG/ML / pseudoephedrine hydrochloride 6 MG/ML Oral Solution	SCD	db0cb6ae-0a4d-4232-805a-f3f3a058261f	6
1098227	dextromethorphan hydrobromide 15 MG / guaifenesin 200 MG / pseudoephedrine hydrochloride 30 MG per 5 ML Oral Solution	SY	db0cb6ae-0a4d-4232-805a-f3f3a058261f	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63102-101-16	63102010116	474 mL in 1 BOTTLE (63102-101-16)	474 ml	2014-09-24	0000-00-00	No	No	Current