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 118 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HISTEX-DM New Formulation	DEXTROMETHORPHAN HBR, PSEUDOEPHEDRINE HCI, AND TRIPROLIDINE HCI	Allegis Pharmaceuticals, LLC	30010401-e5b4-2bd9-e063-6394a90a0b0b	2025-03-10	Warnings	Exact identifier application number: M012
daytime severe cold multi-symptom	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	United Natural Foods, Inc. dba UNFI	cc7c5f1c-76b7-4278-8e2a-5fbc85e022dd	2025-03-08	Warnings	Exact identifier application number: M012
Cold and Head Congestion Relief Severe	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL	WinCo Foods, LLC	a39778ba-1f63-4495-8e9b-44b0bdd7f71a	2025-03-08	Warnings	Exact identifier application number: M012
Extra Strength TYLENOL Severe Cough Plus Sore Throat Day	ACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDE	Kenvue Brands LLC	2e9540e4-bd1d-9370-e063-6294a90affcb	2025-03-07	Warnings	Exact identifier application number: M012
Herbal Cough Drops Original Herb	COUGH DROPS	Topco Associates LLC	2fb22181-aee3-d0bf-e063-6294a90a7865	2025-03-06	Warnings	Exact identifier application number: M012
REVASOL DAYTIME COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Rnv LLC	2f9ddcc3-b913-f8b0-e063-6294a90a93ab	2025-03-05	Warnings	Exact identifier application number: M012
Herbal Throat Drops Lemon Mint Herb	THROAT DROPS	Topco Associates LLC	2fa086b4-3b0e-0df8-e063-6294a90a6769	2025-03-05	Warnings	Exact identifier application number: M012
Redicare Nasal and Sinus Decongestant	REDICARE NASAL AND SINUS DECONGESTANT	Redicare LLC	2f24be68-f30e-d916-e063-6294a90a7e31	2025-03-04	Warnings	Exact identifier application number: M012
Diphenhydramine HCl Oral Solution	DIPHENHYDRAMINE HCL ORAL SOLUTION	Kesin Pharma Corporation	2f871005-de4d-8b2a-e063-6394a90aa43a	2025-03-04	Warnings	Exact identifier application number: M012
CVS Daytime Cough Relief Chews - Citrus Punch	DEXTROMETHORPHAN HBR	CVS	2f885f1b-7ff5-251b-e063-6394a90a656f	2025-03-04	Warnings	Exact identifier application number: M012
CVS Dex-Dox Kids Nighttime Cough Suppressant	DEXTROMETHORPHAN HBR	CVS	2f8b6f5e-399c-b033-e063-6294a90ac3d1	2025-03-04	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL 25 MG	Pioneer Life Sciences, LLC	ff8b096c-8f01-4a8c-a98f-e4aa4d688e95	2025-03-04	Warnings	Exact identifier application number: M012
Menthol Cough Drops Honey Vanilla Flavor	MENTHOL	7-ELEVEN	2f3c43dd-175f-722e-e063-6294a90acff9	2025-02-28	Warnings	Exact identifier application number: M012
Menthol Cough Drops Creamy Strawberry Flavor	MENTHOL AND PECTIN	7-ELEVEN	2f3c3c65-4178-6304-e063-6294a90a51fa	2025-02-28	Warnings	Exact identifier application number: M012
Menthol Cough Drops Creamy Strawberry Flavor	MENTHOL AND PECTIN	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	2efbffd7-bbdd-c5f5-e063-6294a90a15f0	2025-02-25	Warnings	Exact identifier application number: M012
Menthol Cough Drops Honey Vanilla Flavor	MENTHOL	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	2efc46c9-a421-1998-e063-6394a90aeb64	2025-02-25	Warnings	Exact identifier application number: M012
Redicare Cough Drops Cherry Flavored	CHERRY FLAVORED MENTHOL COUGH DROPS	Redicare LLC	2efeaafa-ee96-37ee-e063-6394a90a9a4b	2025-02-25	Warnings	Exact identifier application number: M012
Childrens Allergy	DIPHENHYDRAMINE HCL	Genexa Inc.	e880b8d7-61c3-41cc-e053-2995a90aaaeb	2025-02-20	Warnings	Exact identifier application number: M012
Gencare-Nasal Decongestant PE	PHENYLEPHRINE HYDROCHLORIDE	Pioneer Life Sciences, LLC	596ec923-56a0-4b6e-a69c-8d740feb75a2	2025-02-20	Warnings	Exact identifier application number: M012
Tylenol Cold Plus Flu Severe Day and Tylenol Cold Plus Flu Plus Cough Night 2-pack	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	77a2dc96-73ee-4ca2-b1fe-406995802606	2025-02-19	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