ACTINEL PEDIATRIC

Product NDC: 63102-102
11-digit product format: 631020102
Labeler code: 63102
Product ID: 63102-102_eb2ae74b-0abd-4451-a6a3-f2c5b0fbcfbf
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: 5; 50; 15 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 PEDIATRIC
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXTROMETHORPHAN HYDROBROMIDE	5 mg/5mL
GUAIFENESIN	50 mg/5mL
PSEUDOEPHEDRINE HYDROCHLORIDE	15 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
1098911	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
6bb92d74-4893-40b8-af58-eb307155e876	Available on FDA.report

DailyMed Product Concepts#

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
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
76633df9-0d59-4b88-03ed-21dee1b966f8	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
63102-102-16	2023-10-18	C162847	48780-1	0191ceaa-62b9-198a-e063-dbdaa90aec3e	ACTINEL ® Pediatric
63102-102-16	2023-07-28	C162847	48780-1	0191ceaa-62b9-198a-e063-dbdaa90aec3e	ACTINEL ® Pediatric

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63102-102-16	ACTINEL PEDIATRIC	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
63102-102-16	ML - Milliliter	63102-102	528ff6bd-850c-4865-8444-e57cfbd143cd	1	2015-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	ACTINEL PEDIATRIC (DEXTROMETHORPHAN HBR,GUAIFENESIN,PSEUDOEPHEDRINE HCL) SOLUTION [ACTIPHARMA, INC]	1
GUAIFENESIN	ACTIVE INGREDIENT	495W7451VQ	ACTINEL PEDIATRIC (DEXTROMETHORPHAN HBR,GUAIFENESIN,PSEUDOEPHEDRINE HCL) SOLUTION [ACTIPHARMA, INC]	1
PSEUDOEPHEDRINE HYDROCHLORIDE	ACTIVE INGREDIENT	6V9V2RYJ8N	ACTINEL PEDIATRIC (DEXTROMETHORPHAN HBR,GUAIFENESIN,PSEUDOEPHEDRINE HCL) SOLUTION [ACTIPHARMA, INC]	1
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	ACTINEL PEDIATRIC (DEXTROMETHORPHAN HBR,GUAIFENESIN,PSEUDOEPHEDRINE HCL) SOLUTION [ACTIPHARMA, INC]	1
GUAIFENESIN	ACTIVE MOIETY	495W7451VQ	ACTINEL PEDIATRIC (DEXTROMETHORPHAN HBR,GUAIFENESIN,PSEUDOEPHEDRINE HCL) SOLUTION [ACTIPHARMA, INC]	1
PSEUDOEPHEDRINE	ACTIVE MOIETY	7CUC9DDI9F	ACTINEL PEDIATRIC (DEXTROMETHORPHAN HBR,GUAIFENESIN,PSEUDOEPHEDRINE HCL) SOLUTION [ACTIPHARMA, INC]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	ACTINEL PEDIATRIC (DEXTROMETHORPHAN HBR,GUAIFENESIN,PSEUDOEPHEDRINE HCL) SOLUTION [ACTIPHARMA, INC]	1
CORN SYRUP	INACTIVE INGREDIENT	9G5L16BK6N	ACTINEL PEDIATRIC (DEXTROMETHORPHAN HBR,GUAIFENESIN,PSEUDOEPHEDRINE HCL) SOLUTION [ACTIPHARMA, INC]	1
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	ACTINEL PEDIATRIC (DEXTROMETHORPHAN HBR,GUAIFENESIN,PSEUDOEPHEDRINE HCL) SOLUTION [ACTIPHARMA, INC]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	ACTINEL PEDIATRIC (DEXTROMETHORPHAN HBR,GUAIFENESIN,PSEUDOEPHEDRINE HCL) SOLUTION [ACTIPHARMA, INC]	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	ACTINEL PEDIATRIC (DEXTROMETHORPHAN HBR,GUAIFENESIN,PSEUDOEPHEDRINE HCL) SOLUTION [ACTIPHARMA, INC]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	ACTINEL PEDIATRIC (DEXTROMETHORPHAN HBR,GUAIFENESIN,PSEUDOEPHEDRINE HCL) SOLUTION [ACTIPHARMA, INC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	ACTINEL PEDIATRIC (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
63102-102	ACTINEL PEDIATRIC (DEXTROMETHORPHAN HBR,GUAIFENESIN,PSEUDOEPHEDRINE HCL) SOLUTION [ACTIPHARMA, LLC]	5	Current NDC, Legacy NDC, 1 package rows	20240814_6bb92d74-4893-40b8-af58-eb307155e876.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 111 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MUCUS RELIEF	GUAIFENESIN 400 MG	Pioneer Life Sciences, LLC	8188b66a-5405-4e62-bde6-63ebc1f22b16	2025-07-04	Warnings	Exact identifier application number: M012
nasal	OXYMETAZOLINE HYDROCHLORIDE	Meijer, Inc.	fdeadc2e-43e4-40d5-aebf-0e528f0a8b5a	2025-07-03	Warnings	Exact identifier application number: M012
Cabinet Allergy Relief Refill Diphenhydramine HCI	DIPHENHYDRAMINE HYDROCHLORIDE	Cabinet Health P.B.C.	d47553a4-ca15-4f0a-8177-d743a5c39cc5	2025-07-03	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	Advanced Rx LLC	20e164b8-4cbc-cf3f-e063-6394a90a9d0c	2025-07-02	Warnings	Exact identifier application number: M012
24/7 Life Medicated Chest Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL OINTMENT	Lil' Drug Store Products, Inc.	f03430d4-8dbb-4fc0-e053-2a95a90a119d	2025-07-02	Warnings	Exact identifier application number: M012
DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN	DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN	KJD Pharma Private Limited	b109249a-a0be-41bd-b6ce-ef621b588ddc	2025-07-02	Warnings	Exact identifier application number: M012
Daytime Mucus Relief Severe Congestion and Cough and Nighttime Cold and Flu Maximum Strength	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	CVS Pharmacy	91c803c8-6cf8-4ff6-b376-ea6d65f9f227	2025-07-01	Warnings	Exact identifier application number: M012
WALGREENS Dye Free Chidrens Allergy Chews	DIPHENHYDRAMINE HCL	WALGREENS CO.	cc2fdc6b-8319-47c8-b036-37dbd65d5833	2025-06-30	Warnings	Exact identifier application number: M012
WALGREENS Dye Free Chidrens Allergy Chews	DIPHENHYDRAMINE HCL	WALGREENS CO.	91c369b0-8620-4764-a85d-a86402d9489c	2025-06-30	Warnings	Exact identifier application number: M012
Allergy Relief Diphenhydramine HCl 25mg SoftGel	DIPHENHYDRAMINE HYDROCHLORIDE	Pioneer Life Sciences, LLC	bb9a82b1-ea7a-4d10-bc00-05013e83c4d3	2025-06-30	Warnings	Exact identifier application number: M012
Daytime and Nighttime Cherry Cold and Flu	DAYTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL NIGHTTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	BETTER LIVING BRANDS, LLC	202f0661-461c-0333-e063-6294a90a96b5	2025-06-28	Warnings	Exact identifier application number: M012
Sugar Free Cough Drops	MENTHOL	CVS Pharmacy	f038b713-0721-2bb5-e053-2a95a90a7842	2025-06-26	Warnings	Exact identifier application number: M012
Allergy Relief Diphenhydramine HCl 25mg SoftGel	DIPHENHYDRAMINE HYDROCHLORIDE	NUVICARE LLC	bb728ceb-8eb0-4192-a8b0-742756819a05	2025-06-26	Warnings	Exact identifier application number: M012
ALLERGY RELIEF	DIPHENHYDRAMINE HYDROCHLORIDE	TIME CAP LABORATORIES, INC	7aee34b5-1583-4a8a-8ffb-b17ef2722ac1	2025-06-25	Warnings	Exact identifier application number: M012
ALLERGY RELIEF	DIPHENHYDRAMINE HYDROCHLORIDE	WALGREENS	c0270298-e7c5-e500-e053-2995a90aed23	2025-06-25	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Walmart Inc.	24ff91f2-02db-56a2-e063-6394a90a31c9	2025-06-25	Warnings	Exact identifier application number: M012
Cough and Chest Congestion Maximum Strength	DEXTROMETHORPHAN HBR, GUAIFENESIN	Genexa Inc.	e920b700-30d3-3266-e053-2a95a90a0639	2025-06-24	Warnings	Exact identifier application number: M012
good sense childrens cold cough	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE	L. Perrigo Company	2ffe0fbc-236d-417b-bbfd-5b9294f3c90a	2025-06-23	Warnings	Exact identifier application number: M012
Exchange Select Cough Drop Black Cherry Sugar Free	MENTHOL	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	38034ad2-5eab-9caf-e063-6294a90abb8f	2025-06-20	Warnings	Exact identifier application number: M012
Herbal Cough Drops	HERBAL MENTHOL	Meijer, Inc.	380364be-4e52-fa52-e063-6394a90a713c	2025-06-20	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
1098911	dextromethorphan HBr 5 MG / guaiFENesin 50 MG / pseudoephedrine HCl 15 MG in 5 mL Oral Solution	PSN	6bb92d74-4893-40b8-af58-eb307155e876	6
1098911	dextromethorphan hydrobromide 1 MG/ML / guaifenesin 10 MG/ML / pseudoephedrine hydrochloride 3 MG/ML Oral Solution	SCD	6bb92d74-4893-40b8-af58-eb307155e876	6
1098911	dextromethorphan HBr 5 MG / guaifenesin 50 MG / pseudoephedrine HCl 15 MG per 5 ML Oral Solution	SY	6bb92d74-4893-40b8-af58-eb307155e876	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63102-102-16	63102010216	474 mL in 1 BOTTLE (63102-102-16)	474 ml	2014-09-24	0000-00-00	No	No	Current