Childrens Mucinex Multi-Symptom Cold

Product NDC: 63824-282
11-digit product format: 638240282
Labeler code: 63824
Product ID: 63824-282_5dcc1354-9a08-4781-e063-6294a90a63b6
Type: HUMAN OTC DRUG
Nonproprietary name: Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride
Dosage form: SOLUTION
Route: ORAL
Labeler: Reckitt Benckiser LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2012-07-17
Substance: DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength: 5; 100; 2.5 mg/5mL; mg/5mL; mg/5mL
Pharmacologic classes: Adrenergic alpha1-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-1 Adrenergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	63824-282	63824-282-22	D	Discontinued by firm		2026-10-16
excluded package	package	63824-282	63824-282-64	D	Discontinued by firm		2026-10-16

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 35 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63824-282-22	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63824-282-64	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63824-282-22	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63824-282-64	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63824-282-22	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63824-282-64	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63824-282-22	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63824-282-64	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63824-282-22	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63824-282-64	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63824-282-22	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63824-282-64	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63824-282-22	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63824-282-64	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63824-282-22	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63824-282-64	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63824-282-22	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63824-282-64	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63824-282-22	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63824-282-64	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63824-282-22	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63824-282-64	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63824-282-64	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	63824-282-67	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	63824-282-22	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	63824-282-64	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	63824-282-67	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	63824-282-22	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	63824-282-64	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	63824-282-67	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	63824-282-22	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	63824-282-64	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`

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: Childrens Mucinex Multi-Symptom Cold
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXTROMETHORPHAN HYDROBROMIDE	5 mg/5mL
GUAIFENESIN	100 mg/5mL
PHENYLEPHRINE HYDROCHLORIDE	2.5 mg/5mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e4e263da-1c53-440f-bb80-b7a575843b5a	Product name	1	20260313
d2168cac-a261-415a-9c78-3522859fa720	Product name	3	20251124
bf324df6-7127-7deb-def5-2681c136cd03	Product name	3	20250325
05a8cdd1-eeb8-409e-b938-0778225eca7d	Product name	4	20250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9	Product name	8	20250220
f489e8f3-5c9e-4818-b539-a73587edcfc7	Product name	2	20240229
0f7ae452-206d-4fc4-868d-56fc47074084	Product name	1	20231011
43a1ed49-eae2-4840-8075-cb4b33478540	Product name	1	20230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
b5abe2e3-39a1-43eb-9bff-f3c1653fe3df	Product name	2	20190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814	Product name	3	20150910
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
42f3c020-f1b3-89bc-7bdc-e1f10e680485	Product name	1	20140508
76633df9-0d59-4b88-03ed-21dee1b966f8	Product name	1	20140508
e949165d-714d-e548-2b76-0cb5def16f30	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
63824-282-22	2022-03-07	Children's Mucinex® Multi-Symptom Cold
63824-282-22	2022-03-07	Children's Mucinex® Multi-Symptom Cold
63824-282-64	2022-03-07	Children's Mucinex® Multi-Symptom Cold
63824-282-64	2022-03-07	Children's Mucinex® Multi-Symptom Cold
63824-282-67	2022-03-07	Children's Mucinex® Multi-Symptom Cold
63824-282-67	2022-03-07	Children's Mucinex® Multi-Symptom Cold
63824-282-22	2020-01-31	Children's Mucinex® Multi-Symptom Cold
63824-282-22	2020-01-31	Children's Mucinex® Multi-Symptom Cold
63824-282-64	2020-01-31	Children's Mucinex® Multi-Symptom Cold
63824-282-64	2020-01-31	Children's Mucinex® Multi-Symptom Cold
63824-282-67	2020-01-31	Children's Mucinex® Multi-Symptom Cold
63824-282-67	2020-01-31	Children's Mucinex® Multi-Symptom Cold

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63824-282-22	Childrens Mucinex Multi-Symptom Cold	2 in 1 CELLO PACK	SOLUTION	2	9
63824-282-22	Childrens Mucinex Multi-Symptom Cold	1 in 1 CARTON	SOLUTION	1	9
63824-282-64	Childrens Mucinex Multi-Symptom Cold	1 in 1 CARTON	SOLUTION	1	9
63824-282-64	Childrens Mucinex Multi-Symptom Cold	118 mL in 1 BOTTLE	SOLUTION	118	9
63824-282-67	Childrens Mucinex Multi-Symptom Cold	1 in 1 CARTON	SOLUTION	1	9
63824-282-67	Childrens Mucinex Multi-Symptom Cold	201 mL in 1 BOTTLE	SOLUTION	201	9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63824-282-64	ML - Milliliter	63824-282	64a56fd3-8eec-455e-b290-af980fa60543	1	2014-05-02
63824-282-67	ML - Milliliter	63824-282	a87953c7-830a-4510-838e-c395cd074e61	1	2013-06-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Dextromethorphan Hydrobromide	ACTIVE INGREDIENT	9D2RTI9KYH	CHILDRENS MUCINEX MULTI-SYMPTOM COLD (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [RECKITT BENCKISER LLC]	4
Guaifenesin	ACTIVE INGREDIENT	495W7451VQ	CHILDRENS MUCINEX MULTI-SYMPTOM COLD (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [RECKITT BENCKISER LLC]	4
Phenylephrine Hydrochloride	ACTIVE INGREDIENT	04JA59TNSJ	CHILDRENS MUCINEX MULTI-SYMPTOM COLD (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [RECKITT BENCKISER LLC]	4
Dextromethorphan	ACTIVE MOIETY	7355X3ROTS	CHILDRENS MUCINEX MULTI-SYMPTOM COLD (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [RECKITT BENCKISER LLC]	4
Guaifenesin	ACTIVE MOIETY	495W7451VQ	CHILDRENS MUCINEX MULTI-SYMPTOM COLD (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [RECKITT BENCKISER LLC]	4
Phenylephrine	ACTIVE MOIETY	1WS297W6MV	CHILDRENS MUCINEX MULTI-SYMPTOM COLD (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [RECKITT BENCKISER LLC]	4
anhydrous citric acid	INACTIVE INGREDIENT	XF417D3PSL	CHILDRENS MUCINEX MULTI-SYMPTOM COLD (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [RECKITT BENCKISER LLC]	4
edetate disodium	INACTIVE INGREDIENT	7FLD91C86K	CHILDRENS MUCINEX MULTI-SYMPTOM COLD (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [RECKITT BENCKISER LLC]	4
FD&C red No. 40	INACTIVE INGREDIENT	WZB9127XOA	CHILDRENS MUCINEX MULTI-SYMPTOM COLD (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [RECKITT BENCKISER LLC]	4
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	CHILDRENS MUCINEX MULTI-SYMPTOM COLD (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [RECKITT BENCKISER LLC]	4
propyl gallate	INACTIVE INGREDIENT	8D4SNN7V92	CHILDRENS MUCINEX MULTI-SYMPTOM COLD (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [RECKITT BENCKISER LLC]	4
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	CHILDRENS MUCINEX MULTI-SYMPTOM COLD (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [RECKITT BENCKISER LLC]	4
sodium benzoate	INACTIVE INGREDIENT	OJ245FE5EU	CHILDRENS MUCINEX MULTI-SYMPTOM COLD (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [RECKITT BENCKISER LLC]	4
sorbitol	INACTIVE INGREDIENT	506T60A25R	CHILDRENS MUCINEX MULTI-SYMPTOM COLD (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [RECKITT BENCKISER LLC]	4
sucralose	INACTIVE INGREDIENT	96K6UQ3ZD4	CHILDRENS MUCINEX MULTI-SYMPTOM COLD (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [RECKITT BENCKISER LLC]	4
trisodium citrate dihydrate	INACTIVE INGREDIENT	B22547B95K	CHILDRENS MUCINEX MULTI-SYMPTOM COLD (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [RECKITT BENCKISER LLC]	4
water	INACTIVE INGREDIENT	059QF0KO0R	CHILDRENS MUCINEX MULTI-SYMPTOM COLD (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [RECKITT BENCKISER LLC]	4
xanthan gum	INACTIVE INGREDIENT	TTV12P4NEE	CHILDRENS MUCINEX MULTI-SYMPTOM COLD (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [RECKITT BENCKISER LLC]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63824-282	CHILDRENS MUCINEX MULTI-SYMPTOM COLD (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [RB HEALTH (US) LLC]	8	Current NDC, Legacy NDC, 6 package rows	20231018_60daf6e2-ded8-44e6-bd8d-9d221384adde.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 36 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Panadol Cold and Flu Night	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	Haleon US Holdings LLC	3417993d-8e3c-23d6-e063-6394a90a7d50	2026-04-29	Warnings	Exact identifier application number: M012
Halls Sugar Free Mountain Menthol	MENTHOL	Mondelez Global LLC	509f233e-ff01-8927-e063-6394a90a9929	2026-04-29	Warnings	Exact identifier application number: M012
Broncomiel Adults	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Pharmadel LLC	509c61d3-ae16-be5c-e063-6294a90a68da	2026-04-29	Warnings	Exact identifier application number: M012
Mucus Relief DM Max Maximum Strength	DEXTROMETHORPHAN HBR, GUAIFENESIN	TOP CARE (Topco Associates LLC)	aa1eb90c-e565-455f-8978-6f2f9e00a814	2026-04-29	Warnings	Exact identifier application number: M012
Tussin Cough and Chest Congestion DM adult	DEXTROMETHORPHAN HBR, GUAIFENESIN	Harris Teeter, LLC	e1280355-da81-489f-9bd2-ffea9a68010c	2026-04-29	Warnings	Exact identifier application number: M012
Mucus Relief Childrens	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	TOPCO ASSOCIATES LLC	7b095ec5-9951-4491-9b68-7ac0a7f10053	2026-04-29	Warnings	Exact identifier application number: M012
Mucus Relief Severe Congestion and Cough Maximum Strength	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	TOP CARE (Topco Associates LLC)	98dd0ba6-0109-46b2-92df-11a030984240	2026-04-28	Warnings	Exact identifier application number: M012
Pain, Headache and Congestion	ACETAMINOPHEN, GUAIFENESIN	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	41a77cbb-6a4d-46a4-ab27-c7affa2cc682	2026-04-28	Warnings	Exact identifier application number: M012
ALKA SELTZER COLD Cold Flu and Congestion Severe Fast Dissolve	CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE	Bayer HealthCare LLC.	dd7da15a-4e0b-405f-e053-2995a90a06d2	2026-04-28	Warnings	Exact identifier application number: M012
CAREONE CHILDRENS COLD COUGH	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE	Retail Business Services, LLC	382f7d51-ceb8-4bdf-9bd5-440b50c65cd3	2026-04-28	Warnings	Exact identifier application number: M012
Cold and Flu Daytime Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	L.N.K. International, Inc.	1a520b4f-6a4b-4e37-94c5-9387f2e4c34a	2026-04-27	Warnings	Exact identifier application number: M012
Childrens Multi-Symptom Cold	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Kroger	49a7cd2a-8c0e-2196-e063-6294a90a134a	2026-04-27	Warnings	Exact identifier application number: M012
Guaifenesin,Dextromethorphan Hbr	GUAIFENESIN,DEXTROMETHORPHAN HBR	Softgel Healthcare Pvt Ltd	3e5d978f-cc70-60a5-e063-6394a90a67d3	2026-04-27	Warnings	Exact identifier application number: M012
Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate and Phenylephrine Hydrochloride	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE AND PHENYLEPHRINE HYDROCHLORIDE	Softgel Healthcare Pvt Ltd	36ced59c-12dc-441f-e063-6294a90a3239	2026-04-27	Warnings	Exact identifier application number: M012
Acetaminophen 325mg, Dextromethorphan HBr 10mg and Phenyleprine Hcl 5mg	ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCL	Softgel Healthcare Private Limited	30ab39f3-27cc-5728-e063-6394a90a9cbe	2026-04-27	Warnings	Exact identifier application number: M012
Acetaminophen, Dextromethorphan HBr and Doxylamine Succinate	ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE	Softgel Healthcare Private Limited	353f71f7-81e0-08c2-e063-6294a90acb49	2026-04-27	Warnings	Exact identifier application number: M012
Acetaminophen, Dextromethorphan HBr ,Guaifenesin	ACETAMINOPHEN, DEXTROMETHORPHAN HBR ,GUAIFENESIN	Softgel Healthcare Pvt Ltd	353ef34f-760d-ae92-e063-6294a90a5b4a	2026-04-27	Warnings	Exact identifier application number: M012
DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE	SOFTGEL HEALTHCARE PRIVATE LIMITED	0203d919-dc1f-cca0-e063-6394a90aa1aa	2026-04-27	Warnings	Exact identifier application number: M012
ALKA SELTZER COLD Cold Flu and Congestion Severe Fast Dissolve	CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE	Bayer HealthCare LLC.	507214ad-1e06-fe21-e063-6294a90a59cd	2026-04-27	Warnings	Exact identifier application number: M012
ALKA SELTZER COLD Cold Congestion Severe Day Night Fast Dissolve	ASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE	Bayer HealthCare LLC.	50738a43-7299-270c-e063-6294a90af2cc	2026-04-27	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
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1043543	dextromethorphan HBr 5 MG / guaiFENesin 100 MG / phenylephrine HCl 2.5 MG in 5 mL Oral Solution	PSN	60daf6e2-ded8-44e6-bd8d-9d221384adde	9
1043543	dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution	SCD	60daf6e2-ded8-44e6-bd8d-9d221384adde	9
1043543	dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 20 ML Oral Solution	SY	60daf6e2-ded8-44e6-bd8d-9d221384adde	9
1043543	dextromethorphan HBr 5 MG / guaifenesin 100 MG / phenylephrine HCl 2.5 MG per 5 ML Oral Solution	SY	60daf6e2-ded8-44e6-bd8d-9d221384adde	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63824-282-22	63824028222	2 CARTON in 1 CELLO PACK (63824-282-22) > 1 BOTTLE in 1 CARTON > 118 mL in 1 BOTTLE	2 carton	2012-07-17	0000-00-00	No	No	Current
63824-282-64	63824028264	1 BOTTLE in 1 CARTON (63824-282-64) > 118 mL in 1 BOTTLE	1 bottle	2012-07-17	2024-02-15	No	No	Current
63824-282-67	63824028267	1 BOTTLE in 1 CARTON (63824-282-67) / 201 mL in 1 BOTTLE	1 bottle	2012-07-17	0000-00-00	No	No	Current