Rompe Tos X Adults
- Product NDC
- 69729-785
- 11-digit product format
- 697290785
- Labeler code
- 69729
- Product ID
- 69729-785_30b94710-9f43-fc1e-e063-6294a90a8e9e
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
- Dosage form
- SYRUP
- Route
- ORAL
- Labeler
- OPMX LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-09-18
- Substance
- ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
- Active strength
- 500; 10; 26.66; 400 mg/20mL; mg/20mL; mg/20mL; mg/20mL
- 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
- 2026-12-31
- Current FDA listing
- Yes
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.
| Captured / source date | Dataset | Scope | Package NDC | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 69729-785-06 | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 69729-785-06 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 69729-785-06 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 69729-785-06 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 69729-785-06 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 69729-785-06 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 69729-785-06 | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 69729-785-06 | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 69729-785-06 | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… |
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 Tos X Adults
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 500 mg/20mL |
| PHENYLEPHRINE HYDROCHLORIDE | 10 mg/20mL |
| DEXTROMETHORPHAN HYDROBROMIDE | 26.66 mg/20mL |
| GUAIFENESIN | 400 mg/20mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| 04JA59TNSJ | Internal UNII lookup |
| 9D2RTI9KYH | Internal UNII lookup |
| 495W7451VQ | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1790651 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 05abb2db-d22e-90b5-e063-6294a90ace3f | Available on FDA.report |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 69729-785-06 | 2025-12-23 | C162847 | 48780-1 | 2cef2736-9975-d83d-e063-dadaa90ab31f | Rompe Tos X Adult |
| 69729-785-06 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-9975-d83d-e063-dadaa90ab31f | Rompe Tos X Adult |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69729-785-06 | Rompe Tos X Adults | 177 mL in 1 BOTTLE, PLASTIC | SYRUP | 177 | 3 | |
| 69729-785-06 | Rompe Tos X Adults | 1 in 1 CARTON | SYRUP | 1 | 3 |
DailyMed Dashboard NDC Coverage#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Mentholatum No Mess Vaporizing Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | The Mentholatum Company | f4675bc1-01cc-4a33-a3bf-bfc99230fe32 | 2024-12-17 | Warnings | M012 |
| Mentholatum Cherry Vaporizing Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | The Mentholatum Company | de01225a-eabb-4972-bf3a-3e5a0e44abef | 2024-12-17 | Warnings | M012 |
| Rite Aid Chest Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | Rite Aid Corporation | 198a666a-3f34-4e4f-89e8-ec7f412f00af | 2024-12-17 | Warnings | M012 |
| Equate Childrens Vaporizing | CAMPHOR, EUCALYPTUS OIL, MENTHOL | Wal-Mart Stores Inc | 372e66a6-1f1f-4aa3-a2ed-d215fafee9b9 | 2024-12-17 | Warnings | M012 |
| Caring Mill Chest Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | FSA Store Inc. | caa83419-c332-4b92-b151-22da2fa85289 | 2024-12-17 | Warnings | M012 |
| Always Save Chest Congestion Relief GUAF | GUAIFENESIN | Valu Merch | 9d81d88b-2db9-4891-942b-fecb1be961dd | 2024-12-17 | Warnings | M012 |
| Kroger EXTRA STRENGTH Acetaminophen PM Caplet | ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE | The Kroger Co. | 24a75ffa-c2a7-71a9-e063-6394a90a0e25 | 2024-12-17 | Warnings | M012 |
| Allergy 36ct, Caseys 4good | DIPHENHYDRAMINE HCL 25MG | Lil' Drug Store Products, Inc. | 04b78b23-424d-9762-e063-6394a90a52e3 | 2024-12-16 | Warnings | M012 |
| Sinus Relief, Caseys 4good | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL CAPLET, FILM-COATED | Lil' Drug Store Products, Inc. | 033837c0-fa68-a38d-e063-6394a90a9832 | 2024-12-16 | Warnings | M012 |
| DayQuil Severe plus VapoCOOL Cold and Flu, Travel BASIX | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Lil' Drug Store Products, Inc. | cfab9b80-0580-4482-b6e3-0aab875b5797 | 2024-12-16 | Warnings | M012 |
| Allergy Relief, 24-7 Lift by 7-Eleven | DIPHENHYDRAMINE HCL 25MG | Lil' Drug Store products, Inc. | 04c9db9a-95ef-3a48-e063-6294a90a4e8e | 2024-12-16 | Warnings | M012 |
| Cold and Flu Daytime Severe, 24/7 Life | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL TABLET | Lil' Drug Store Products, Inc. | 05cc7185-d49d-82a3-e063-6294a90a568e | 2024-12-16 | Warnings | M012 |
| Cold and Flu Nighttime Severe, 24-7 Life | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Lil' Drug Store products, Inc. | 05d0410f-164e-e7ee-e063-6394a90a2aaa | 2024-12-16 | Warnings | M012 |
| tussin dm max daytime nighttime | DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFESESIN | CVS Pharmacy | 6feaf29e-de06-4c94-912c-a76ea2cbd8c1 | 2024-12-16 | Warnings | M012 |
| Leader Childrens Multi Symptom Cold | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | CARDINAL HEALTH 110, LLC. DBA LEADER | 169ff9cf-fcf5-46a6-b460-259421f2ec07 | 2024-12-16 | Warnings | M012 |
| Childrens Mucus and Cough Relief | DEXTROMETHORPHAN HBR, GUAIFENESIN | CARDINAL HEALTH 110, LLC. DBA LEADER | 125eeb3d-0ee2-45bb-81c0-4ca699979886 | 2024-12-16 | Warnings | M012 |
| Dextromethorphan HBr 15 mg Liquid Gels | DEXTROMETHORPHAN HBR | RUGBY LABORATORIES | cf3cc387-6642-43fd-999d-688fdaf65d4f | 2024-12-14 | Warnings | M012 |
| Allergy Relief Dye-Free Softgel | DIPHENHYDRAMINE HYDROCHLORIDE | CVS PHARMACY, INC | 60b1bb79-3ed1-438b-a27f-f7fbc108d114 | 2024-12-14 | Warnings | M012 |
| Rycontuss Cherry Flavor | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Okendpharma, Inc. | c91798fa-48ab-47a0-92da-4d44c2aafde0 | 2024-12-13 | Warnings | M012 |
| Mentholatum Lavender Vaporizing Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | The Mentholatum Company | 6f208c05-617d-492a-a016-e9d6be3c971f | 2024-12-13 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1790651 | acetaminophen 250 MG / dextromethorphan HBr 13.33 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG in 10 mL Oral Solution | PSN | 05abb2db-d22e-90b5-e063-6294a90ace3f | 3 |
| 1790651 | acetaminophen 25 MG/ML / dextromethorphan hydrobromide 1.33 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution | SCD | 05abb2db-d22e-90b5-e063-6294a90ace3f | 3 |
| 1790651 | acetaminophen 250 MG / dextromethorphan HBr 13.33 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG per 10 ML Oral Solution | SY | 05abb2db-d22e-90b5-e063-6294a90ace3f | 3 |
| 1790651 | acetaminophen 500 MG / dextromethorphan HBr 26.66 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 20 ML Oral Solution | SY | 05abb2db-d22e-90b5-e063-6294a90ace3f | 3 |
| 1790651 | APAP 25 MG/ML / Dextromethorphan Hydrobromide 1.33 MG/ML / Guaifenesin 20 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML Oral Solution | SY | 05abb2db-d22e-90b5-e063-6294a90ace3f | 3 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 69729-785-06 | 69729078506 | 1 BOTTLE, PLASTIC in 1 CARTON (69729-785-06) / 177 mL in 1 BOTTLE, PLASTIC | 2023-09-18 | No | No | Current |