Rompe Pecho

Product NDC: 58593-235
11-digit product format: 585930235
Labeler code: 58593
Product ID: 58593-235_3e6375e6-6668-3453-e063-6394a90add02
Type: HUMAN OTC DRUG
Nonproprietary name: Dextromethorphan HBr, Guaifenesin, Phenylephrine HCL
Dosage form: LIQUID
Route: ORAL
Labeler: Efficient Laboratories Inc
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2007-10-01
Marketing end: 2027-03-31
Substance: DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength: 10; 100; 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
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded package	package	58593-235	58593-235-04	D	Discontinued by firm	2026-10-27
excluded package	package	58593-235	58593-235-06	D	Discontinued by firm	2026-10-27
excluded package	package	58593-235	58593-235-08	D	Discontinued by firm	2026-10-27
excluded package	package	58593-235	58593-235-29	D	Discontinued by firm	2026-10-27

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, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	58593-235-29	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	58593-235-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	58593-235-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	58593-235-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	58593-235-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	58593-235-29	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	58593-235-08	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	58593-235-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	58593-235-29	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	58593-235-08	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	58593-235-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	58593-235-29	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	58593-235-08	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	58593-235-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	58593-235-29	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	58593-235-08	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	58593-235-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	58593-235-29	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	58593-235-08	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	58593-235-04	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	58593-235-29	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	58593-235-08	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	58593-235-04	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	58593-235-29	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	58593-235-08	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	58593-235-04	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	58593-235-29	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	58593-235-08	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	58593-235-04	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	58593-235-29	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	58593-235-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	58593-235-08	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	58593-235-04	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	58593-235-08	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	58593-235-04	`557ba5c1ecfa…`	`9c80585c8c6e…`

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: Rompe Pecho
Brand name suffix: CF

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXTROMETHORPHAN HYDROBROMIDE	10 mg/5mL
GUAIFENESIN	100 mg/5mL
PHENYLEPHRINE HYDROCHLORIDE	5 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
04JA59TNSJ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1044949	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
96c4dee1-6e66-4442-a7e3-56e874414c17	Available on FDA.report

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
58593-235-04	2023-08-03	Drug Facts
58593-235-06	2023-08-03	Drug Facts
58593-235-08	2023-08-03	Drug Facts
58593-235-10	2023-08-03	Drug Facts
58593-235-29	2023-08-03	Drug Facts
58593-235-04	2023-07-28	Drug Facts
58593-235-06	2023-07-28	Drug Facts
58593-235-08	2023-07-28	Drug Facts
58593-235-10	2023-07-28	Drug Facts
58593-235-29	2023-07-28	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
58593-235-04	Rompe PechoCF	118 mL in 1 BOTTLE	LIQUID	118	26
58593-235-06	Rompe PechoCF	178 mL in 1 BOTTLE	LIQUID	178	26
58593-235-08	Rompe PechoCF	237 mL in 1 BOTTLE	LIQUID	237	26
58593-235-10	Rompe PechoCF	10 mL in 1 POUCH	LIQUID	10	26
58593-235-29	Rompe PechoCF	296 mL in 1 BOTTLE	LIQUID	296	26

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	ROMPE PECHO CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EFFICIENT LABORATORIES INC]	5
GUAIFENESIN	ACTIVE INGREDIENT	495W7451VQ	ROMPE PECHO CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EFFICIENT LABORATORIES INC]	5
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	ROMPE PECHO CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EFFICIENT LABORATORIES INC]	5
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	ROMPE PECHO CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EFFICIENT LABORATORIES INC]	5
GUAIFENESIN	ACTIVE MOIETY	495W7451VQ	ROMPE PECHO CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EFFICIENT LABORATORIES INC]	5
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	ROMPE PECHO CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EFFICIENT LABORATORIES INC]	5
CAULOPHYLLUM THALICTROIDES ROOT	INACTIVE INGREDIENT	JTJ6HH6YEH	ROMPE PECHO CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EFFICIENT LABORATORIES INC]	5
ECHINACEA, UNSPECIFIED	INACTIVE INGREDIENT	4N9P6CC1DX	ROMPE PECHO CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EFFICIENT LABORATORIES INC]	5
EUCALYPTUS GLOBULUS LEAF	INACTIVE INGREDIENT	S546YLW6E6	ROMPE PECHO CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EFFICIENT LABORATORIES INC]	5
GINKGO	INACTIVE INGREDIENT	19FUJ2C58T	ROMPE PECHO CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EFFICIENT LABORATORIES INC]	5
GLYCYRRHIZA GLABRA	INACTIVE INGREDIENT	2788Z9758H	ROMPE PECHO CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EFFICIENT LABORATORIES INC]	5
GOLDENSEAL	INACTIVE INGREDIENT	ZW3Z11D0JV	ROMPE PECHO CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EFFICIENT LABORATORIES INC]	5
HONEY	INACTIVE INGREDIENT	Y9H1V576FH	ROMPE PECHO CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EFFICIENT LABORATORIES INC]	5
HOREHOUND	INACTIVE INGREDIENT	K08036XEJV	ROMPE PECHO CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EFFICIENT LABORATORIES INC]	5
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	ROMPE PECHO CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EFFICIENT LABORATORIES INC]	5
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	ROMPE PECHO CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EFFICIENT LABORATORIES INC]	5
MYRRH	INACTIVE INGREDIENT	JC71GJ1F3L	ROMPE PECHO CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EFFICIENT LABORATORIES INC]	5
POTASSIUM SORBATE	INACTIVE INGREDIENT	1VPU26JZZ4	ROMPE PECHO CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EFFICIENT LABORATORIES INC]	5
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	ROMPE PECHO CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EFFICIENT LABORATORIES INC]	5
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	ROMPE PECHO CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EFFICIENT LABORATORIES INC]	5
PRUNUS SEROTINA BARK	INACTIVE INGREDIENT	5D48E975HA	ROMPE PECHO CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EFFICIENT LABORATORIES INC]	5
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	ROMPE PECHO CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EFFICIENT LABORATORIES INC]	5
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	ROMPE PECHO CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EFFICIENT LABORATORIES INC]	5
ULMUS RUBRA BARK	INACTIVE INGREDIENT	91QY4PXU8Q	ROMPE PECHO CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EFFICIENT LABORATORIES INC]	5
VERBASCUM DENSIFLORUM LEAF	INACTIVE INGREDIENT	9936O846LI	ROMPE PECHO CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EFFICIENT LABORATORIES INC]	5
WATER	INACTIVE INGREDIENT	059QF0KO0R	ROMPE PECHO CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EFFICIENT LABORATORIES INC]	5
ZINC SULFATE	INACTIVE INGREDIENT	89DS0H96TB	ROMPE PECHO CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EFFICIENT LABORATORIES INC]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58593-235	ROMPE PECHO CF (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [EFFICIENT LABORATORIES INC]	25	Current NDC, Legacy NDC, 5 package rows	20250328_96c4dee1-6e66-4442-a7e3-56e874414c17.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 173 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Akin	GUAIFENESIN	Southern Sales & Service, Inc.	bb2c9f21-6765-4286-bd71-de01cdf4c4e9	2023-11-29	Warnings	Exact identifier application number: M012
Akin Cough Formula DM	DEXTROMETHORPHAN, GUAIFENESIN	Southern Sales & Service, Inc.	1f2f9b4c-ecf0-4ff6-861a-063f8a9ef74a	2023-11-29	Warnings	Exact identifier application number: M012
diphenhydramine hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Simpex Pharma Pvt. Ltd	82771f6a-8b3d-4ffa-8b35-09c2faf3582c	2023-11-29	Warnings	Exact identifier application number: M012
SIMPEX Guaifenesin	GUAIFENESIN	Simpex Pharma Pvt. Ltd	1594f9d6-0c48-42bf-b76b-d621f215179a	2023-11-29	Warnings	Exact identifier application number: M012
Stona	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Sato Pharmaceutical Co., Ltd.	8b89f50d-88f8-4773-92ea-5ada61766056	2023-11-28	Warnings	Exact identifier application number: M012
Stona	DEXTROMETHORPHAN HYDROBROMIDE	Sato Pharmaceutical Co., Ltd.	1ccc9e56-32a4-450f-8412-5814b6aef285	2023-11-28	Warnings	Exact identifier application number: M012
Neo-Synephrine Maximum	PHENYLEPHRINE HYDROCHLORIDE	BF ASCHER AND CO INC	ab8682a4-1f66-6709-e053-2995a90a8b4a	2023-11-16	Warnings	Exact identifier application number: M012
Neo-Synephrine Regular	PHENYLEPHRINE HYDROCHLORIDE	BF ASCHER AND CO INC	ab860c10-b8cf-3f92-e053-2a95a90a7317	2023-11-16	Warnings	Exact identifier application number: M012
Neo-Synephrine Mild	PHENYLEPHRINE HYDROCHLORIDE	BF ASCHER AND CO INC	9b8e9162-e4da-14d9-e053-2995a90a2269	2023-11-16	Warnings	Exact identifier application number: M012
Universal Vaporizing Chest Rub	MENTHOL AND CAMPHOR AND EUCALYPTUS	Universal Distribution Center LLC	b1d25572-da21-408d-aab3-3a0741dfff12	2023-11-16	Warnings	Exact identifier application number: M012
Daytime Cold and Flu Severe, Caseys 4goog	ACETAMINOPHEN, PHENYLEPHRINE, DEXTROMETHORPHAN HBR, GUAIFENESIN TABLET, FILM COATED	Lil' Drug Store Products, Inc.	0334259d-587e-b2d5-e063-6394a90a3e56	2023-11-14	Warnings	Exact identifier application number: M012
Stona Cough	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Sato Pharmaceutical Co., Ltd.	0b638db4-5ed3-4665-abcd-f95e677adbd8	2023-11-12	Warnings	Exact identifier application number: M012
Tylenol Sinus Severe	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Jones Healthcare Group - Packaging Services, Inc	6c90b415-4c5f-49e5-beb6-4cf225797b21	2023-11-06	Warnings	Exact identifier application number: M012
Tylenol Cold Plus Flu Severe Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Jones Healthcare Group - Packaging Services, Inc	8b8582c0-8aef-482f-9738-2f1d4e325d64	2023-11-06	Warnings	Exact identifier application number: M012
Cold and Flu Severe Daytime/Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE	Topco Associates LLC	27ade5f8-2003-4dc6-9244-42676791e1f8	2023-11-06	Warnings	Exact identifier application number: M012
Benadryl Allergy Ultratab	DIPHENHYDRAMINE HYDROCHLORIDE	Jones Healthcare Group - Packaging Services, Inc	ec2070df-8a8a-4cd1-8830-62655433fb3b	2023-11-05	Warnings	Exact identifier application number: M012
Daytime Nighttime Ultra Concentrated Cold and Flu	DAYTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR AND NIGHTTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR, DOXYLAMINE SUCCINATE	TARGET CORPORATION	093eed84-79b1-7914-e063-6394a90a37af	2023-11-03	Warnings	Exact identifier application number: M012
Cough Drops	MENTHOL	Topco Associates LLC	eff68377-2273-6c6c-e053-2995a90a36b2	2023-11-03	Warnings	Exact identifier application number: M012
Sugar Free Cough Drops	MENTHOL	Topco Associates LLC	096bbcaa-fce1-0fc2-e063-6294a90ad597	2023-11-03	Warnings	Exact identifier application number: M012
TopCare Nite Time SEVERE Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Topco Associates LLC	adc8edf5-ebbe-4d94-9018-aa0dbe118112	2023-11-03	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
1044949	dextromethorphan HBr 20 MG / guaiFENesin 200 MG / phenylephrine HCl 10 MG in 10 mL Oral Solution	PSN	96c4dee1-6e66-4442-a7e3-56e874414c17	26
1044949	dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 1 MG/ML Oral Solution	SCD	96c4dee1-6e66-4442-a7e3-56e874414c17	26
1044949	dextromethorphan HBr 10 MG / guaifenesin 100 MG / phenylephrine HCl 5 MG per 5 ML Oral Solution	SY	96c4dee1-6e66-4442-a7e3-56e874414c17	26
1044949	dextromethorphan HBr 20 MG / guaifenesin 200 MG / phenylephrine HCl 10 MG per 10 ML Oral Solution	SY	96c4dee1-6e66-4442-a7e3-56e874414c17	26

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
58593-235-04	58593023504	118 mL in 1 BOTTLE (58593-235-04)	118 ml	2015-01-01	0000-00-00	No	No	Current
58593-235-06	58593023506	178 mL in 1 BOTTLE (58593-235-06)	178 ml	2007-10-01	0000-00-00	No	No	Current
58593-235-08	58593023508	237 mL in 1 BOTTLE (58593-235-08)	237 ml	2015-01-01	0000-00-00	No	No	Current
58593-235-10	58593023510	10 mL in 1 POUCH (58593-235-10)	10 ml	2019-01-01	2027-03-31	No	No	Current
58593-235-29	58593023529	296 mL in 1 BOTTLE (58593-235-29)	296 ml	2015-01-01	0000-00-00	No	No	Current